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NCT02337062 · ClinicalTrials.gov registry record · Phase 3
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
A Phase 3 study of PONV, sponsored by Acacia Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,147
- Enrollment target
- 20
- Study locations
NCT02337062: Completed Phase 3 study of PONV, sponsored by Acacia Pharma.
NCT02337062 is a Phase 3 study of PONV that has completed, run by Acacia Pharma. The registered enrollment target is 1,147 participants, above the 166-participant average among 3 other PONV trials with a reported enrollment target (591% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02337062, a Phase 3 study of PONV, has completed, sponsored by Acacia Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,147 participants
- Enrollment target
- 20
- Study locations
Study Summary
A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).
Primary Outcome
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG APD421
Study Locations (20)
Other
- University Hospital - Besançon
- Centre Hospitalier Lyon-Sud - Lyon
- Centre Hospitalier de Mulhouse - Mulhouse
- Hopital Foch - Paris
- CHU de Hautepierre - Strasbourg
- HELIOS Klinikum Aue - Aue
Texas
- First Street Surgical Center - Bellaire
- Victory Medical Center Houston - Houston
- Memorial Hermann-Memorial City Hospital - Houston
New York
- Albany Medical Center Hospital - Albany
- Stony Brook Medicine - Stony Brook
North Carolina
- Duke University Medical Center - Durham
- Wake Forest University School of Medicine - Winston-Salem
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Alabama
- Helen Keller Hospital - Sheffield
California
- UCSF School of Medicine - San Francisco
Florida
- Jackson Memorial Hospital - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT02337062 record still lists
NCT02337062 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, above the 166-participant average among 3 other PONV trials with a reported enrollment target (591% higher).
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.
NCT02337062 names 20 study sites across 10 states, led by Other, Texas, New York.
Frequently Asked Questions
What is clinical trial NCT02337062 about?
NCT02337062 is a clinical study titled "Phase IIIb Study of APD421 in Combination as PONV Prophylaxis". A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).
What is the current status of trial NCT02337062?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,147 participants. The study started on 2015-02. Estimated completion is 2015-09.
What conditions does trial NCT02337062 study?
This clinical trial studies the following conditions: PONV.
What interventions are being tested in trial NCT02337062?
The interventions under investigation include: Placebo (DRUG), APD421 (DRUG).
Who is sponsoring clinical trial NCT02337062?
This trial is sponsored by Acacia Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02337062 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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