Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01991860 · ClinicalTrials.gov registry record · Phase 3
US Phase III Study of APD421 in PONV
A Phase 3 study of PONV, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
- 1
- Study location
NCT01991860: Completed Phase 3 study of PONV, sponsored by Acacia Pharma.
NCT01991860 is a Phase 3 study of PONV that has completed, run by Acacia Pharma. The registered enrollment target is 364 participants, below the 427-participant average among 3 other PONV trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991860, a Phase 3 study of PONV, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
- 1
- Study location
Study Summary
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Primary Outcome
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%.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG APD421- Amisulpride for IV injection
Study Locations (1)
North Carolina
- Duke - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01991860 record still lists
NCT01991860 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 427-participant average among 3 other PONV trials with a reported enrollment target (15% lower).
The record links to 1 condition, with PONV appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01991860 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01991860 about?
NCT01991860 is a clinical study titled "US Phase III Study of APD421 in PONV". A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
What is the current status of trial NCT01991860?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2013-08. Estimated completion is 2014-01.
What conditions does trial NCT01991860 study?
This clinical trial studies the following conditions: PONV.
What interventions are being tested in trial NCT01991860?
The interventions under investigation include: Placebo (DRUG), APD421- Amisulpride for IV injection (DRUG).
Who is sponsoring clinical trial NCT01991860?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01991860 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PONV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04510597 · 364 participants · Phase 3
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
- NCT05098132 · 364 participants · Phase 1
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
- NCT05330221 · 364 participants · NA
Project 2: ACHIEVE- HF
- NCT05673148 · 364 participants · Phase 3
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia