Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-29 @ 6:30 PM
Study NCT ID:
NCT01510704
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2012-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Dose-ranging 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gabrielfox@acaciapharma.com', 'title': 'Dr Gabriel Fox', 'organization': 'Acacia Pharma Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 54, 'otherNumAffected': 52, 'seriousNumAtRisk': 54, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Low Dose APD421', 'description': '1mg dose level', 'otherNumAtRisk': 58, 'otherNumAffected': 50, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Mid Dose APD421', 'description': '5mg dose level', 'otherNumAtRisk': 50, 'otherNumAffected': 39, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'High Dose APD421', 'description': '20mg dose level', 'otherNumAtRisk': 53, 'otherNumAffected': 46, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}], 'seriousEvents': [{'term': 'POST PROCEDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'POST PROCEDURAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'WOUND HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Nausea or Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Low Dose APD421', 'description': '1mg dose level'}, {'id': 'OG002', 'title': 'Mid Dose APD421', 'description': '5mg dose level'}, {'id': 'OG003', 'title': 'High Dose APD421', 'description': '20mg dose level'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Single-dose IV placebo'}, {'id': 'FG001', 'title': 'Low Dose APD421', 'description': 'Single-dose 1 mg IV APD421'}, {'id': 'FG002', 'title': 'Mid Dose APD421', 'description': 'Single-dose 5 mg IV APD421'}, {'id': 'FG003', 'title': 'High Dose APD421', 'description': 'Single-dose 20 mg IV APD421'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '215', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo'}, {'id': 'BG001', 'title': 'Low Dose APD421', 'description': '1mg dose level'}, {'id': 'BG002', 'title': 'Mid Dose APD421', 'description': '5mg dose level'}, {'id': 'BG003', 'title': 'High Dose APD421', 'description': '20mg dose level'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '50', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '50', 'spread': '16.2', 'groupId': 'BG002'}, {'value': '50.7', 'spread': '15.7', 'groupId': 'BG003'}, {'value': '49.9', 'spread': '14.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2012-01-12', 'resultsFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-15', 'studyFirstPostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Nausea or Vomiting', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '23872464', 'type': 'DERIVED', 'citation': 'Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Male or female patients ≥ 18 years of age\n2. Ability and willingness to give written informed consent\n3. Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:\n\n 1. Hysterectomy (any surgical technique)\n 2. Cholecystectomy (any surgical technique)\n 3. Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia\n4. Patients with at least 2 of the following risk factors for PONV:\n\n 1. Past history of PONV and/or motion sickness\n 2. Habitual non-smoking status\n 3. Female sex\n 4. Expected to receive opioid analgesia post-operatively\n5. American Society of Anesthesiologists (ASA) risk score I-III\n6. Adequate cardiac, hepatic and renal function\n\n * QTc interval \\< 500 ms\n * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\< 5 x upper limit normal (ULN)\n * Bilirubin \\< 3 x ULN\n * Creatinine \\< 2 x ULN\n7. Adequate haematological function\n\n * Haemoglobin ≥ 9 g/dL\n * White blood count ≥ 3.0 x 109/L\n * Platelet count ≥ 100 x 109/L\n8. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) between the date of screening and at least 48 hours after administration of study drug.\n\nExclusion Criteria\n\n1. Patients undergoing outpatient/day case surgery\n2. Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery\n3. Patients undergoing intra-thoracic, transplant or central nervous system surgery\n4. Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block\n5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed\n6. Patients receiving the active ingredient of APD421 for any indication within the last 2 weeks\n7. Patients who are allergic to the active ingredient or any of the excipients of APD421\n8. Patients with a pre-existing vestibular disorder or history of dizziness\n9. Patients with pre-existing nausea or vomiting in the 24 hours before surgery\n10. Patients treated with regular anti-emetic therapy including corticosteroids\n11. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin\n12. Patients being treated with levodopa\n13. Patients who are pregnant or breast feeding\n14. Patients with a history of alcohol abuse\n15. Patients with pre-existing, clinically significant cardiac arrhythmia\n16. Patients diagnosed with Parkinson's disease\n17. Patients who have received anti-cancer chemotherapy in the previous 4 weeks\n18. Patients with a history of epilepsy\n19. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study\n20. Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)"}, 'identificationModule': {'nctId': 'NCT01510704', 'briefTitle': 'Phase II Dose-ranging Study of APD421 in PONV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acacia Pharma Ltd'}, 'officialTitle': 'Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'DP10006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose APD421', 'description': '1mg dose level', 'interventionNames': ['Drug: APD421']}, {'type': 'EXPERIMENTAL', 'label': 'Mid Dose APD421', 'description': '5mg dose level', 'interventionNames': ['Drug: APD421']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose APD421', 'description': '20mg dose level', 'interventionNames': ['Drug: APD421']}], 'interventions': [{'name': 'APD421', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['High Dose APD421', 'Low dose APD421', 'Mid Dose APD421']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital mère enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nancy', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hautepierre Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Aue', 'country': 'Germany', 'facility': 'HELIOS Klinikum Aue', 'geoPoint': {'lat': 50.59034, 'lon': 12.70657}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universität Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Philipps University', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospitals of Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Peter Kranke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Würzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acacia Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}