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NCT01427270 · ClinicalTrials.gov registry record · Phase 3
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
A Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
- 20
- Study locations
NCT01427270 is a Phase 3 study of Low Back Pain that has completed, run by Purdue Pharma. The registered enrollment target is 455 participants, roughly in line with the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target. The trial reports 20 study locations across 4 states.
The verdict
NCT01427270, a Phase 3 study of Low Back Pain, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxycodone/Naloxone controlled-release
- DRUG Oxycodone HCl controlled-release
Study Locations (20)
Alabama
- Investigational Site - Alabaster
- Investigational Site - Birmingham
- Investigational Site - Gulf Shores
- Investigational Site - Homewood
- Investigational Site - Huntsville
- Investigational Site - Mobile
Arizona
- Investigational Site - Goodyear
- Investigational Site - Goodyear
- Investigational Site - Phoenix
- Investigational Site - Phoenix
- Investigational Site - Tempe
- Investigational Site - Tucson
California
- Investigational Site - Anaheim
- Investigational Site - Anaheim
- Investigational Site - Anaheim
- Investigational Site - Chino
- Investigational Site - Fresno
- Investigational Site - Fresno
Arkansas
- Investigational Site - Hot Springs
- Investigational Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01427270
The ClinicalTrials.gov registry entry for NCT01427270 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 455 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01427270 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01427270 about?
NCT01427270 is a clinical study titled "Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain". The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
What is the current status of trial NCT01427270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2011-08. Estimated completion is 2014-10.
What conditions does trial NCT01427270 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT01427270?
The interventions under investigation include: Placebo (DRUG), Oxycodone/Naloxone controlled-release (DRUG), Oxycodone HCl controlled-release (DRUG).
Who is sponsoring clinical trial NCT01427270?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01427270 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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