NCT01484652

Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Bunion

Interventions

Type	Name	Description
DRUG	COV795	2 tablets taken every 12 hours
DRUG	Placebo	2 tablets taken every 12 hours

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-12-02
• Last updated: 2016-10-21
• Results posted: 2014-07-02

Locations

5 sites across 1 country: United States