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NCT01427283 · ClinicalTrials.gov registry record · Phase 3

A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

A Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.

Completed
Registry status
Phase 3
Development phase
450
Enrollment target
20
Study locations

NCT01427283: Completed Phase 3 study of Low Back Pain, sponsored by Purdue Pharma.

NCT01427283 is a Phase 3 study of Low Back Pain that has completed, run by Purdue Pharma. The registered enrollment target is 450 participants, below the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01427283, a Phase 3 study of Low Back Pain, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 3
Development phase
450 participants
Enrollment target
20
Study locations

Study Summary

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation 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

Low Back Pain

Interventions

  • DRUG Placebo
  • DRUG Oxycodone/Naloxone controlled-release
  • DRUG Oxycodone HCl controlled-release

Study Locations (20)

California

  • Investigational Site - Anaheim
  • Investigational Site - Anaheim
  • Investigational Site - Artesia
  • Investigational Site - Cerritos
  • Investigational Site - Chino
  • Investigational Site - El Cajon
  • Investigational Site - Encino

Arizona

  • Investigational Site - Mesa
  • Investigational Site - Phoenix
  • Investigational Site - Phoenix
  • Investigational Site - Sun Lakes
  • Investigational Site - Tucson
  • Investigational Site - Tucson

Alabama

  • Investigational Site - Alabaster
  • Investigational Site - Birmingham
  • Investigational Site - Birmingham
  • Investigational Site - Foley
  • Investigational Site - Mobile

Arkansas

  • Investigational Site - Little Rock
  • Investigational Site - Sherwood

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2011-08
Est. Completion 2014-10
Phase Phase 3
Purdue Pharma

54 total trials

What the finished NCT01427283 record still lists

NCT01427283 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target (10% lower).

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.

NCT01427283 names 20 study sites across 4 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT01427283 about?

NCT01427283 is a clinical study titled "A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain". The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation wh...

What is the current status of trial NCT01427283?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2011-08. Estimated completion is 2014-10.

What conditions does trial NCT01427283 study?

This clinical trial studies the following conditions: Low Back Pain.

What interventions are being tested in trial NCT01427283?

The interventions under investigation include: Placebo (DRUG), Oxycodone/Naloxone controlled-release (DRUG), Oxycodone HCl controlled-release (DRUG).

Who is sponsoring clinical trial NCT01427283?

This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01427283 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 NCT01427283's enrollment target sits among peer trials

450 15th of 122 higher than 108 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

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Related registry views

Source: ClinicalTrials.gov NCT01427283, the US trial registry maintained by the National Library of Medicine. NCT01427283 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.