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NCT02646566 · ClinicalTrials.gov registry record · Phase 3
Study of APD421 as PONV Treatment (Prior Prophylaxis)
A Phase 3 study of Postoperative Nausea and Vomiting, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 705
- Enrollment target
- 8
- Study locations
NCT02646566: Completed Phase 3 study of Postoperative Nausea and Vomiting, sponsored by Acacia Pharma.
NCT02646566 is a Phase 3 study of Postoperative Nausea and Vomiting that has completed, run by Acacia Pharma. The registered enrollment target is 705 participants, above the 363-participant average among 10 other Postoperative Nausea and Vomiting trials with a reported enrollment target (94% higher). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02646566, a Phase 3 study of Postoperative Nausea and Vomiting, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 705 participants
- Enrollment target
- 8
- Study locations
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 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG APD421
Study Locations (8)
Other
- CHU de Hautepierre - Strasbourg
- HELIOS Klinikum Aue - Aue
- Universität Heidelberg - Heidelberg
- Philipps University - Marburg
North Carolina
- Duke University Medical Center - Durham
- Wake Forest University School of Medicine - Winston-Salem
Florida
- Jackson Memorial Hospital - Miami
Ohio
- Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
What the finished NCT02646566 record still lists
NCT02646566 is an interventional study that assigns participants to a tested intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, above the 363-participant average among 10 other Postoperative Nausea and Vomiting trials with a reported enrollment target (94% higher).
The record links to 1 condition, with Postoperative Nausea and Vomiting appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02646566 lists 8 locations in 4 states (Other, North Carolina, Florida).
Frequently Asked Questions
What is clinical trial NCT02646566 about?
NCT02646566 is a clinical study titled "Study of APD421 as PONV Treatment (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 had prior PONV prophylaxis.
What is the current status of trial NCT02646566?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 705 participants. The study started on 2016-03. Estimated completion is 2017-01.
What conditions does trial NCT02646566 study?
This clinical trial studies the following conditions: Postoperative Nausea and Vomiting.
What interventions are being tested in trial NCT02646566?
The interventions under investigation include: Placebo (DRUG), APD421 (DRUG).
Who is sponsoring clinical trial NCT02646566?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02646566 being conducted?
This trial has 8 study locations across Florida, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02646566's enrollment target sits among peer trials
705 2nd of 10 the highest of 10 other Postoperative Nausea and Vomiting trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Nausea and Vomiting 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.
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