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NCT01400139 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
A Phase 3 study of Chronic Nonmalignant and Nonneuropathic Pain, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 922
- Enrollment target
- 20
- Study locations
NCT01400139: Completed Phase 3 study of Chronic Nonmalignant and Nonneuropathic Pain, sponsored by Purdue Pharma.
NCT01400139 is a Phase 3 study of Chronic Nonmalignant and Nonneuropathic Pain that has completed, run by Purdue Pharma. The registered enrollment target is 922 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400139, a Phase 3 study of Chronic Nonmalignant and Nonneuropathic Pain, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 922 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
Primary Outcome
Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.
Conditions Studied
Interventions
- DRUG Hydrocodone bitartrate q24h film-coated tablets
Study Locations (20)
California
- ACRI -Phase1, LLC - Anaheim
- United Clinical Research Center, Inc. - Anaheim
- Med Center - Carmichael
- Research Center of Fresno, Inc. - Fresno
- TriWest Research Associates - La Mesa
- Torrance Clinical Research - Lomita
- Skyline Research, LLC - Long Beach
- Lotus Clinical Research, LLC - Pasadena
- Center for Clinical Research, Inc - Richmond
- Northern California Research - Sacramento
- Encompass Clinical Research - Spring Valley
Florida
- Meridien Research - Bradenton
- Innovative Research of West Florida, Inc. - Clearwater
- Avail Clinical Research, LLC - DeLand
- Clinical Physiology Associates - Fort Myers
Arizona
- Arizona Research Center - Phoenix
- Genova Clinical Research - Tucson
- Quality of Life Medical & Research Center, LLC - Tucson
Alabama
- Alliance Clinical Research - Birmingham
Connecticut
- Chase Medical Research, LLC - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 922 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01400139 record still lists
NCT01400139 is an interventional study that assigns participants to a tested intervention. The registered 922 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Chronic Nonmalignant and Nonneuropathic Pain appearing as the primary indexed condition, and to 1 intervention - of which Hydrocodone bitartrate q24h film-coated tablets is the first listed.
NCT01400139 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01400139 about?
NCT01400139 is a clinical study titled "Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.". The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
What is the current status of trial NCT01400139?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 922 participants. The study started on 2011-07. Estimated completion is 2013-10.
What conditions does trial NCT01400139 study?
This clinical trial studies the following conditions: Chronic Nonmalignant and Nonneuropathic Pain.
What interventions are being tested in trial NCT01400139?
The interventions under investigation include: Hydrocodone bitartrate q24h film-coated tablets (DRUG).
Who is sponsoring clinical trial NCT01400139?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01400139 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400139's enrollment target sits among peer trials
922 344th of 2000 higher than 1,656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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