At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 329 enrolled
Drug / intervention
COV795 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating COV795 and Placebo for Pain, Postoperative and Bunion. Completed, enrolled 329 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Bunion
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedDec 2011
Primary CompletionAug 2012
Study CompletionSep 2012
TodayJul 2026
First PostedDec 2, 2011
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.6 years ago
Interventions
COV795drug
2 tablets taken every 12 hours
Placebodrug
2 tablets taken every 12 hours