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Hydrocodone ER in OA or Low Back Pain
NCT01240863Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Aug 2011
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- hydrocodone
- Conditions
- osteoarthritis (OA)low back pain (LBP)
01
Overview
Phase 3, randomised, double-blind trial in osteoarthritis (OA) and low back pain (LBP) comparing Hydrocodone ER with Placebo (2 arms). Primary endpoint: Weekly Average Pain Intensity at 12 weeks. Started Nov 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydrocodone ER
Hydrocodone ER at stabilized dose
Placebo
Matching placebo (with taper for first 2 weeks)
03
Who it enrols
Patients with moderate to severe pain from osteoarthritis or low back pain requiring opioid treatment. Must be opioid-tolerant or naive but not on high doses (>135mg oxycodone equivalent). Excludes substance abuse history.
04
Endpoints
Primary
Weekly Average Pain Intensity
Secondary
Percentage of Participants Withdrawn
Time to Discontinuation From the Study
Participants With wAPI Increase From Baseline Exceeding 33%
Participants With wAPI Increase From Baseline Exceeding 50%
Weekly Average Pain Intensity Scores
Weekly Average Worst Pain Intensity
Clinician Assessment of Patient Function
Patient Assessment of Function
05
Results
Not all primary endpoints met
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