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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 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.

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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.

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

Sponsor

Purdue Pharma

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01427283

The ClinicalTrials.gov registry entry for NCT01427283 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 500-participant average among 122 other Low Back Pain trials with a reported enrollment target (10% lower). 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.

NCT01427283 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.