Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Low Back Pain
In brief
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
Key facts
- Study ID
- NCT01452529
- Run by
- Purdue Pharma LP
- People needed
- 905
- Starts
- 2011-10-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2020-03-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Coastal Clinical Research, Inc. — Mobile, Alabama, United States
- Arizona Research Center — Phoenix, Arizona, United States
- Redpoint Research — Phoenix, Arizona, United States
- Genova Clinical Research — Tucson, Arizona, United States
- Quality of Life Medical & Research Center, LLC — Tucson, Arizona, United States
- Redpoint Research — Tucson, Arizona, United States
- ACRI-Phase 1, LLC — Anaheim, California, United States
- Orange County Research Institute — Anaheim, California, United States
- United Clinical Research Center, Inc. — Anaheim, California, United States
- Research Center of Fresno, Inc. — Fresno, California, United States
- TriWest Research Associates — La Mesa, California, United States
- Torrance Clinical Research Institute Inc. — Lomita, California, United States
- Skyline Research, LLC — Long Beach, California, United States
- Center for Clinical Research, Inc. — Richmond, California, United States
- Northern California Research — Sacramento, California, United States
- Encompass Clinical Research — Spring Valley, California, United States
- Chase Medical Research, LLC — Waterbury, Connecticut, United States
- Orthopedic Research Institute — Boynton Beach, Florida, United States
- Meridien Research — Bradenton, Florida, United States
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
- Avail Clinical Research, LLC — DeLand, Florida, United States
- Florida Health Center — Fort Lauderdale, Florida, United States
- Clinical Physiology Associates — Fort Myers, Florida, United States
- AGA Clinical Trials — Hialeah, Florida, United States
- Alliance Clinical Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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