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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 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. The trial reports 20 study locations across 5 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01400139
The ClinicalTrials.gov registry entry for NCT01400139 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 922 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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