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NCT02678286 · ClinicalTrials.gov registry record · Phase 3
Evaluation of N1539 Following Abdominoplasty Surgery
A Phase 3 study, sponsored by Baudax Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT02678286: Completed Phase 3 study, sponsored by Baudax Bio.
NCT02678286 is a Phase 3 study that has completed, run by Baudax Bio. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02678286, a Phase 3 study, has completed, sponsored by Baudax Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.
Primary Outcome
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference
Interventions
- DRUG Intravenous Placebo
- DRUG N1539
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02678286 record still lists
NCT02678286 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Intravenous Placebo is the first listed.
NCT02678286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02678286 about?
NCT02678286 is a clinical study titled "Evaluation of N1539 Following Abdominoplasty Surgery". The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.
What is the current status of trial NCT02678286?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2016-01. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02678286?
The interventions under investigation include: Intravenous Placebo (DRUG), N1539 (DRUG).
Who is sponsoring clinical trial NCT02678286?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02678286's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 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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