16 completed, 1 active not recruiting, 1 withdrawn. 8 Phase 2, 7 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 7, Active not recruiting 1 |
| Phase 3 | 7 | Completed 6, Active not recruiting 1 |
| Phase 1 | 4 | Completed 4 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients Amisulpride Injection, Dexamethasone - Nausea and Vomiting, Postoperative | Phase 2 / Phase 3 | Completed | Acacia Pharma Ltd | 453 | 2024-01-18 | 2025-06-25 |
| Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment Rescue Post-Operative Nausea and Vomiting (PONV) treatment according to the standard of care (SOC), Amisulpride - Nausea and Vomiting, Postoperative | Withdrawn | Acacia Pharma Ltd | 2022-11-01 | 2023-04-07 | ||
| Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures Remimazolam - Pediatric ALL | Phase 2 / Phase 3 | Active not recruiting | Acacia Pharma Ltd | 100 | 2021-11-15 | 2025-07-01 |
| PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment Amisulpride IV, Amisulpride Oral Tablet - Renal Disease, End Stage | Phase 1 | Completed | Acacia Pharma Ltd | 12 | 2021-06-03 | 2021-12-13 |
| Study of APD421 With and Without Ondansetron APD421, Placebo, Ondansetron - Postoperative Nausea and Vomiting | Phase 1 | Completed | Acacia Pharma Ltd | 30 | 2018-07-17 | 2018-10-01 |
| Mass-balance Study of [14C]-APD421 in Healthy Volunteers 14C-APD421 - Post-operative Nausea and Vomiting | Phase 1 | Completed | Acacia Pharma Ltd | 6 | 2016-08-01 | 2019-06-25 |
| Study of APD421 as PONV Treatment (Prior Prophylaxis) APD421, Placebo - Postoperative Nausea and Vomiting | Phase 3 | Completed | Acacia Pharma Ltd | 705 | 2016-03-01 | 2019-01-22 |
| Study of APD421 as PONV Treatment (no Prior Prophylaxis) APD421, Placebo - Postoperative Nausea and Vomiting | Phase 3 | Completed | Acacia Pharma Ltd | 568 | 2015-09-01 | 2019-01-22 |
| Phase IIIb Study of APD421 in Combination as PONV Prophylaxis APD421, Placebo - PONV | Phase 3 | Completed | Acacia Pharma Ltd | 1147 | 2015-02-01 | 2019-03-20 |
| Thorough QT Study of Intravenous Amisulpride APD421 5 mg, APD421 40 mg, Moxifloxacin - Healthy | Phase 1 | Completed | Acacia Pharma Ltd | 40 | 2013-11-01 | 2018-11-29 |
| Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy Ondansetron, Placebo, Dexamethasone - CINV | Phase 2 | Completed | Acacia Pharma Ltd | 342 | 2013-10-01 | 2020-11-25 |
| US Phase III Study of APD421 in PONV APD421- Amisulpride for IV injection, Placebo - PONV | Phase 3 | Completed | Acacia Pharma Ltd | 364 | 2013-08-01 | 2019-02-12 |
| European Phase III Study of APD421 in PONV APD421, Placebo - PONV | Phase 3 | Completed | Acacia Pharma Ltd | 368 | 2013-07-01 | 2019-08-20 |
| Phase II Dose-ranging Study of APD421 in PONV APD421, Placebo - Postoperative Nausea and Vomiting | Phase 2 | Completed | Acacia Pharma Ltd | 215 | 2012-01-01 | 2019-03-05 |
| Proof-of-concept (PoC) Study of APD515 APD515, Placebo - Xerostomia in Advanced Cancer Patients | Phase 2 | Completed | Acacia Pharma Ltd | 32 | 2011-09-01 | 2013-05-16 |
| Phase II Proof-of-concept Study of APD421 APD421 - Chemotherapy-induced Nausea and Vomiting | Phase 2 | Completed | Acacia Pharma Ltd | 51 | 2011-02-01 | 2012-09-25 |
| Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV) APD405, Placebo - Postoperative Nausea and Vomiting | Phase 2 | Completed | Acacia Pharma Ltd | 257 | 2009-05-01 | 2011-03-29 |
| Pilot Study of APD209 in Cancer Cachexia APD209 - Cancer-related Cachexia | Phase 2 | Completed | Acacia Pharma Ltd | 13 | 2009-03-01 | 2012-01-13 |
Postoperative Nausea and Vomiting (10) · Vomiting (2) · Cachexia (1) · Kidney Failure, Chronic (1) · Neoplasms (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1)
Amisulpride (5) · Dexamethasone (2) · Ondansetron (2) · Calcium Dobesilate (1) · Injections, Intravenous (1) · Moxifloxacin (1) · fosaprepitant (1) · remimazolam (1)
United States (9) · France (7) · Germany (7) · Denmark (4) · United Kingdom (4) · Canada (1) · Netherlands (1) · Switzerland (1)
Gabriel Fox, MB BChir (4) · Peter Kranke, MD (2) · Andrew Davies, MD (1) · Gabriel Fox, MD (1) · Keith Candiotti, MD (1) · Kumar Belani, MD (1) · Lynn Bichajian, MD (1) · Muna Albayaty (1) · Pierre Diemunsch, MD (1) · Tong J Gan, MD (1)
PMID 22546895, PMID 23872464, PMID 30488222, PMID 31094774, PMID 31819674, PMID 31913911