Trials / Completed
CompletedNCT00325949
A Study of Pain Relief in Low Back Pain
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 770 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended release hydrocodone and acetaminophen (Vicodin CR) | 2 tablets BID |
| DRUG | hydrocodone/acetaminophen extended release (Vicodin CR) | 1 tablet BID |
| DRUG | placebo | 2 tablets BID |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-05-01
- Completion
- 2007-06-01
- First posted
- 2006-05-15
- Last updated
- 2011-07-25
Locations
63 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00325949. Inclusion in this directory is not an endorsement.