Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-24 @ 7:10 AM
Study NCT ID:
NCT00373334
Status:
COMPLETED
Last Update Posted:
2009-11-18
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016567', 'term': 'Nizatidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmcgowan@braintreelabs.com', 'phone': '781-843-2202', 'title': 'Clinical Operations Manager', 'organization': 'Braintree Laboratories, Inc.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the principal investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Nizatidine 2.5 mg/kg b.i.d.', 'otherNumAtRisk': 43, 'otherNumAffected': 27, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nizatidine 5.0 mg/kg b.i.d.', 'otherNumAtRisk': 50, 'otherNumAffected': 31, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Conservative Measures Only', 'otherNumAtRisk': 45, 'otherNumAffected': 31, 'seriousNumAtRisk': 45, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nizatidine 2.5 mg/kg b.i.d.'}, {'id': 'OG001', 'title': 'Nizatidine 5.0 mg/kg b.i.d.'}, {'id': 'OG002', 'title': 'Conservative Measures Only'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.528', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nizatidine 2.5 mg/kg b.i.d.'}, {'id': 'OG001', 'title': 'Nizatidine 5.0 mg/kg b.i.d.'}, {'id': 'OG002', 'title': 'Conservative Measures Only'}], 'classes': [{'title': 'Better', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.746', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.262', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all patients that took drug and reached the 8 week study timepoint.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nizatidine 2.5 mg/kg b.i.d.'}, {'id': 'OG001', 'title': 'Nizatidine 5.0 mg/kg b.i.d.'}, {'id': 'OG002', 'title': 'Conservative Measures Only'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.609', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.938', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all patients that took drug and reached the 8 week study timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nizatidine 2.5 mg/kg Twice Daily', 'description': 'low dose nizatidine plus Conservative Measures'}, {'id': 'FG001', 'title': 'Nizatidine 5.0 mg/kg Twice Daily', 'description': 'high dose nizatidine plus Conservative Measures'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo plus Conservative Measures\n\nConservative Measures included:\n\nHypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nizatidine 2.5 mg/kg b.i.d.'}, {'id': 'BG001', 'title': 'Nizatidine 5.0 mg/kg b.i.d.'}, {'id': 'BG002', 'title': 'Conservative Measures Only'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', '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': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'dispFirstSubmitDate': '2009-01-22', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-17', 'studyFirstSubmitDate': '2006-09-07', 'dispFirstSubmitQcDate': '2009-10-09', 'resultsFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2006-09-07', 'dispFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-09', 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success', 'timeFrame': '8 weeks', 'description': 'The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.'}], 'secondaryOutcomes': [{'measure': 'Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief', 'timeFrame': '8 weeks', 'description': 'Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.'}, {'measure': 'Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity', 'timeFrame': '8 weeks', 'description': 'Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.'}]}, 'conditionsModule': {'keywords': ['gastroesophageal reflux disease', 'GERD', 'heartburn'], 'conditions': ['Gastroesophageal Reflux Disease', 'GERD', 'Heartburn']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '30 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients age 30 days up to 1 year at Visit 1.\n* Subjects must have a documented medical diagnosis of gastroesophageal reflux disease (GERD), confirmed by either endoscopy or pH monitoring, or by evaluation of baseline symptoms.\n* Subjects must be greater than the 3rd percentile of weight and height for their age.\n* Parents/guardians are competent and willing to provide consent and sign and date the institutional review board (IRB) approved consent form.\n* Parents/guardians are willing to adhere to study requirements, including applying the conservative GERD management methods.\n* Conservative GERD management methods have failed to adequately control GERD symptoms by Visit 2.\n* Parent/guardian and infant live in the same household.\n* Qualifying caregiver questionnaire score at Visits 1 \\& 2.\n\nExclusion Criteria:\n\n* Any known esophageal disease or disorder, other than reflux esophagitis.\n* Any active gastroduodenal ulceration, or clinical or endoscopic evidence of active gastrointestinal bleeding.\n* Any prior esophageal or gastric surgery.\n* Concurrent serious systemic disorders, including chronic respiratory disease, chronic neurologic disease, chronic renal disease, chronic liver disease.\n* Subjects with clinically significant abnormal laboratory findings at screening.\n* Premature infants \\< 37 weeks gestation at birth.\n* Infants with prior neonatal intensive care unit admission for any reason.\n* Hematemesis or apparent life-threatening events (ALTE).\n* Concurrent treatment with any chronic medication except by permission of the study sponsor.\n* Treatment with a histamine 2 receptor antagonist (H2RA), antacid, sucralfate, prostaglandin, or motility agent within 3 days before Visit 1; treatment with a proton pump inhibitor within 7 days before Visit 1.\n* Requirement or likely requirement for a medical procedure or surgery during the study.\n* Known hypersensitivity to an H2RA including nizatidine.\n* Receipt of any investigational agent within the previous 30 days before randomization.\n* Poor medical or psychiatric risks for therapy with an investigational drug, in the opinion of the investigator.\n* Any condition in parent/guardian associated with poor subject compliance e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.'}, 'identificationModule': {'nctId': 'NCT00373334', 'briefTitle': 'Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel, Multicenter Study of Axid (Nizatidine) Oral Solution in the Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms in Infants Age 30 Days-1 Year', 'orgStudyIdInfo': {'id': 'BLI-AX-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: nizatidine (axid)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: nizatidine (axid)']}, {'type': 'SHAM_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'nizatidine (axid)', 'type': 'DRUG', 'description': 'nizatidine (axid)', 'armGroupLabels': ['1']}, {'name': 'nizatidine (axid)', 'type': 'DRUG', 'description': 'nizatidine (axid)', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'city': 'Madiera', 'state': 'California', 'country': 'United States'}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Tifton', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 31.45046, 'lon': -83.5085}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45014', 'city': 'Fairfield', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.34589, 'lon': -84.5605}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15202', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37043', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77495', 'city': 'Missouri City', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61857, 'lon': -95.53772}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}], 'overallOfficials': [{'name': 'John McGowan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Braintree Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John McGowan, Clinical Operations Manager', 'oldOrganization': 'Braintree Laboratories, Inc.'}}}}