Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-07 @ 1:12 PM
Study NCT ID:
NCT01991860
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
US Phase III Study of APD421 in PONV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007275', 'term': 'Injections, Intravenous'}, {'id': 'D000077582', 'term': 'Amisulpride'}], 'ancestors': [{'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gabrielfox@acaciapharma.com', 'phone': '44-(0)1223-919764', 'title': 'Dr Gabriel Fox', 'organization': 'Acacia Pharma Ltd'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations and caveats in this study.'}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'APD421 5mg Dose', 'description': 'A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 169, 'seriousNumAtRisk': 176, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 160, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia Postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Bood Prolactin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'seriousEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Anaemia Postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Post Procedural Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Post Operative Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '2-sided', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after the end of surgery', 'description': "The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With no Nausea.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after end of surgery', 'description': 'Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With no Emesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after end of surgery', 'description': 'Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With no Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after end of surgery', 'description': 'Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after the end of surgery', 'description': 'No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With no Significant Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after the end of surgery', 'description': 'Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score ≥ 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With "Total Response"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 at 5mg', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A 2mL dose of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Yates's continuity correction"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after the end of surgery', 'description': 'Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5mg APD421', 'description': 'A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2mL of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Of the 364 patients enrolled in the study (i.e. signed informed consent form), 22 patients were not randomised and not dosed. Of these, 4 withdrew their consent, 3 did not comply with the protocol procedures and 15 were not dosed for other unspecified reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5mg Dose APD421', 'description': 'A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Single dose placebo given through intravenous (IV) administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '53.0', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 342 patients were randomised and dosed, comprising 176 randomised to APD421 and 166 to placebo. Of these, 4 patients from the APD421 group and 2 patients from the placebo group discontinued prematurely after randomisation'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2016-07-28', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2013-11-11', 'dispFirstSubmitQcDate': '2016-07-28', 'resultsFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2013-11-18', 'dispFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-05', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Response', 'timeFrame': '24 hours after the end of surgery', 'description': "The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With no Nausea.', 'timeFrame': '24 hours after end of surgery', 'description': 'Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1.'}, {'measure': 'Number of Participants With no Emesis', 'timeFrame': '24 hours after end of surgery', 'description': 'Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)'}, {'measure': 'Number of Participants With no Use of Rescue Medication', 'timeFrame': '24 hours after end of surgery', 'description': 'Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.'}, {'measure': 'The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication', 'timeFrame': '24 hours after the end of surgery', 'description': 'No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.'}, {'measure': 'The Number of Participants With no Significant Nausea', 'timeFrame': '24 hours after the end of surgery', 'description': 'Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score ≥ 4.'}, {'measure': 'Number of Participants With "Total Response"', 'timeFrame': '24 hours after the end of surgery', 'description': 'Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PONV']}, 'descriptionModule': {'briefSummary': 'A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age\n* Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital\n\nExclusion Criteria:\n\n* Patients scheduled for outpatient/day case surgery\n* Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery\n* Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block\n* Patients who are expected to remain ventilated for a period after surgery\n* Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed'}, 'identificationModule': {'nctId': 'NCT01991860', 'briefTitle': 'US Phase III Study of APD421 in PONV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acacia Pharma Ltd'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'DP10015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APD421', 'description': 'APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.', 'interventionNames': ['Drug: APD421- Amisulpride for IV injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'APD421- Amisulpride for IV injection', 'type': 'DRUG', 'otherNames': ['Amisulpride for IV injection'], 'description': 'APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia', 'armGroupLabels': ['APD421']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Tong J Gan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acacia Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}