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

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01427283

Run by

Purdue Pharma LP

People needed

450

Starts

2011-08-01

Expected to finish

2014-10-01

Last updated by the study team

2015-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Investigational Site — Birmingham, Alabama, United States
• Investigational Site — Birmingham, Alabama, United States
• Investigational Site — Foley, Alabama, United States
• Investigational Site — Mobile, Alabama, United States
• Investigational Site — Mesa, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Sun Lakes, Arizona, United States
• Investigational Site — Tucson, Arizona, United States
• Investigational Site — Tucson, Arizona, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Sherwood, Arkansas, United States
• Investigational Site — Anaheim, California, United States
• Investigational Site — Anaheim, California, United States
• Investigational Site — Artesia, California, United States
• Investigational Site — Cerritos, California, United States
• Investigational Site — Chino, California, United States
• Investigational Site — El Cajon, California, United States
• Investigational Site — Encino, California, United States
• Investigational Site — Fountain Valley, California, United States
• Investigational Site — Fresno, California, United States
• Investigational Site — Garden Grove, California, United States
• Investigational Site — Garden Grove, California, United States
• Investigational Site — Laguna Hills, California, United States
• Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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