Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-29 @ 12:11 AM
Study NCT ID:
NCT00468559
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2007-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3/Safety & Efficacy of Esomeprazole in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AZTrial_Results_Posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open-label Phase', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).', 'otherNumAtRisk': 98, 'otherNumAffected': 26, 'seriousNumAtRisk': 98, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Double Blind Esomeprazole', 'description': 'Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.', 'otherNumAtRisk': 39, 'otherNumAffected': 19, 'seriousNumAtRisk': 39, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Double Blind Placebo', 'description': 'Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.', 'otherNumAtRisk': 41, 'otherNumAffected': 20, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chlamydial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Failure To Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Poor Peripheral Circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Syncytial Virus Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rotavirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': 'Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'reporting cumulative discontinuations'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': 'Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting cumulative discontinuations. Results for the analysis of the secondary variable, time to discontinuation due to any cause, were identical to that found for the primary variable, time to discontinuation due to symptom.'}, {'type': 'SECONDARY', 'title': 'Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': "The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient's GERD-related symptoms over the last 7 days as:\n\nNone Mild Moderate Severe", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': "Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.040', 'spread': '0.560', 'groupId': 'OG000'}, {'value': '0.090', 'spread': '0.610', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.060', 'spread': '0.580', 'groupId': 'OG000'}, {'value': '0.190', 'spread': '0.590', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.120', 'spread': '0.480', 'groupId': 'OG000'}, {'value': '0.030', 'spread': '0.580', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind Esomeprazole', 'description': 'In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.'}, {'id': 'OG001', 'title': 'Double Blind Placebo', 'description': 'Participants in this group received placebo during the double-blind treatment withdrawal phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.090', 'spread': '0.480', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '0.610', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Open-label treatment period (2 weeks)', 'description': 'Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '95 patients received open-label esomeprazole during the open-label phase.'}, {'type': 'SECONDARY', 'title': 'Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Open Label phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.'}, {'type': 'SECONDARY', 'title': 'Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.'}, {'type': 'SECONDARY', 'title': 'Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.'}, {'type': 'SECONDARY', 'title': 'Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '83 patients were analyzed at the screening timepoint, 83 patients were analyzed at week 1 and 78 patients were analyzed at Week 2 due to discontinuations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Esomeprazole', 'description': 'Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.'}, {'id': 'FG001', 'title': 'Double Blind Esomeprazole'}, {'id': 'FG002', 'title': 'Double Blind Placebo'}], 'periods': [{'title': 'Open-label Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants received open-label esomeprazole during this phase of the study', 'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '18 patients discontinued (were not randomized into the double-blind treatment withdrawal phase)', 'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind, Treatment-withdrawal Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants aged 1 to 11 months inclusive with a clinical diagnosis of suspected Gastroesophageal Reflux Disease (GERD), symptomatic GERD, or endoscopically proven GERD were enrolled across the USA France Germany and Poland. All patients were symptomatic at study entry.', 'preAssignmentDetails': 'All participants received 2-weeks open label esomeprazole (Open-label phase) according to baseline weight (3 to 5kg: 2.5mg; \\>5 to 7.5kg:5mg; \\>7.5-12kg:10mg). Following the open-label phase, those with symptom improvement of at least one category in the physician global assessment were eligible to be randomized into the withdrawal phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double Blind Esomeprazole'}, {'id': 'BG001', 'title': 'Double Blind Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2007-04-30', 'resultsFirstSubmitDate': '2009-06-03', 'studyFirstSubmitQcDate': '2007-04-30', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-06', 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': 'Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': 'Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.'}, {'measure': 'Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': "The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient's GERD-related symptoms over the last 7 days as:\n\nNone Mild Moderate Severe"}, {'measure': "Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)", 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)', 'description': "Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account."}, {'measure': 'Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.'}, {'measure': 'Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.'}, {'measure': 'Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.'}, {'measure': 'Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)', 'timeFrame': 'Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained', 'description': 'Change from baseline in symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.'}, {'measure': "Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)", 'timeFrame': 'Open-label treatment period (2 weeks)', 'description': 'Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.'}, {'measure': 'Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)', 'timeFrame': 'Open Label phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.'}, {'measure': 'Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.'}, {'measure': 'Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.'}, {'measure': 'Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)', 'timeFrame': 'Open Label Phase (Screening plus two weeks)', 'description': 'Symptom severity (Severity is scored as 0-4 \\[none, mild moderate, severe\\]). For each participant, The score is the mean severity in each 7-day period.'}]}, 'conditionsModule': {'keywords': ['pediatrics', 'neonates'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'referencesModule': {'references': [{'pmid': '26422097', 'type': 'DERIVED', 'citation': 'Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.'}, {'pmid': '26121349', 'type': 'DERIVED', 'citation': 'Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.'}, {'pmid': '22241513', 'type': 'DERIVED', 'citation': 'Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=440&filename=CSR-D9614C00096.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=440&filename=CSR-D9614C00096.pdf', 'label': 'CSR-D9614C00096.pdf'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)\n* patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams\n\nExclusion Criteria:\n\n* patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)\n* patients with a history of acute life-threatening event"}, 'identificationModule': {'nctId': 'NCT00468559', 'briefTitle': 'Phase 3/Safety & Efficacy of Esomeprazole in Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive', 'orgStudyIdInfo': {'id': 'D9614C00096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Esomeprazole', 'description': 'This is an open label, run-in phase. All patients received Esomeprazole.', 'interventionNames': ['Drug: Open Label Run In Esomeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Double Blind Esomeprazole', 'description': 'This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.', 'interventionNames': ['Drug: Double Blind Esomeprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double Blind Placebo', 'description': 'This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.', 'interventionNames': ['Drug: Double Blind Placebo']}], 'interventions': [{'name': 'Open Label Run In Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)', 'armGroupLabels': ['Open Label Esomeprazole']}, {'name': 'Double Blind Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)', 'armGroupLabels': ['Double Blind Esomeprazole']}, {'name': 'Double Blind Placebo', 'type': 'DRUG', 'description': 'Double Blind Placebo', 'armGroupLabels': ['Double Blind Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'city': 'Lille', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Nurberg', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Marta Ilueca', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Jennifer Heckman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Jill McGuinn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}