Trials / Completed
CompletedNCT01451385
Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | COV795 | COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg) |
Timeline
- Start date
- 2011-09-20
- Primary completion
- 2012-06-18
- Completion
- 2012-06-18
- First posted
- 2011-10-13
- Last updated
- 2020-09-18
- Results posted
- 2020-09-17
Locations
42 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01451385. Inclusion in this directory is not an endorsement.