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NCT02449291 · ClinicalTrials.gov registry record · Phase 3
Study of APD421 as PONV Treatment (no Prior Prophylaxis)
A Phase 3 study, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT02449291: Completed Phase 3 study, sponsored by Acacia Pharma.
NCT02449291 is a Phase 3 study that has completed, run by Acacia Pharma. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02449291, a Phase 3 study, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study Summary
Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.
Primary Outcome
The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.
Interventions
- DRUG Placebo
- DRUG APD421
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02449291 record still lists
NCT02449291 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02449291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02449291 about?
NCT02449291 is a clinical study titled "Study of APD421 as PONV Treatment (no Prior Prophylaxis)". Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.
What is the current status of trial NCT02449291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2015-09. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02449291?
The interventions under investigation include: Placebo (DRUG), APD421 (DRUG).
Who is sponsoring clinical trial NCT02449291?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02449291's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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