Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
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 |
What the finished NCT01427270 record still lists
NCT01427270 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target.
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01427270's enrollment target sits among peer trials
455 13th of 122 higher than 109 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain 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
-
Nonpharmacologic Pain Management in FQHC Primary Care Clinics
RECRUITING · Phase 3
-
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
COMPLETED · Phase 3
-
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
COMPLETED · Phase 3
-
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
COMPLETED · Phase 3
-
Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
COMPLETED · Phase 3
-
Acupuncture Analgesia in Relation to Psychiatric Comorbidity
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05541016 · 455 participants · Phase 2
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
- NCT06079346 · 455 participants · Phase 2
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
- NCT06504446 · 455 participants · Phase 2
Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough
- NCT06725030 · 455 participants
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia