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NCT01484652 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 329
- Enrollment target
NCT01484652: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT01484652 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 329 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484652, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 329 participants
- Enrollment target
Study Summary
The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain following bunionectomy.
Primary Outcome
Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.
Interventions
- DRUG Placebo
- DRUG COV795
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01484652 record still lists
NCT01484652 is an interventional study that assigns participants to a tested intervention. The registered 329 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 (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01484652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484652 about?
NCT01484652 is a clinical study titled "Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension". The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain following bunionectomy.
What is the current status of trial NCT01484652?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 329 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01484652?
The interventions under investigation include: Placebo (DRUG), COV795 (DRUG).
Who is sponsoring clinical trial NCT01484652?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01484652's enrollment target sits among peer trials
329 1074th of 2000 higher than 927 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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