Trials / Completed
CompletedNCT06545097
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Full Abdominoplasty
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 279 (actual)
- Sponsor
- Tris Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
Detailed description
This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cebranopadol 400 ug | Once daily |
| DRUG | Cebranopadol 200 ug | Once daily on Day 2 |
| DRUG | Placebo | Once daily for 2 days |
Timeline
- Start date
- 2024-09-03
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2024-08-09
- Last updated
- 2026-01-22
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06545097. Inclusion in this directory is not an endorsement.