At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 376 enrolled
Drug / intervention
COV795drug
Likely dose
COV795 15 mgfrom 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.
An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating COV795 for Osteoarthritis and Low Back Pain. Completed, enrolled 376 participants across 42 sites.
Detailed Summary
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Low Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedOct 2011
Primary CompletionJun 2012
TodayJul 2026
First PostedOct 13, 2011
Enrollment StartSep 20, 2011
Primary CompletionJun 18, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.7 years ago
Interventions
COV795drug
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)