Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe 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 (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.

Key facts

Study ID

NCT01427270

Run by

Purdue Pharma LP

People needed

455

Starts

2011-08-01

Expected to finish

2014-10-01

Last updated by the study team

2014-11-07

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 — Gulf Shores, Alabama, United States
• Investigational Site — Homewood, Alabama, United States
• Investigational Site — Huntsville, Alabama, United States
• Investigational Site — Mobile, Alabama, United States
• Investigational Site — Goodyear, Arizona, United States
• Investigational Site — Goodyear, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Tempe, Arizona, United States
• Investigational Site — Tucson, Arizona, United States
• Investigational Site — Hot Springs, Arkansas, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Anaheim, California, United States
• Investigational Site — Anaheim, California, United States
• Investigational Site — Anaheim, California, United States
• Investigational Site — Chino, California, United States
• Investigational Site — Fresno, California, United States
• Investigational Site — Fresno, California, United States
• Investigational Site — Glendale, California, United States
• Investigational Site — La Mesa, California, United States
• Investigational Site — Laguna Hills, California, United States
• Investigational Site — Long Beach, California, United States
• Investigational Site — Los Angeles, California, United States
• Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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