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Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

Back Pain Lower Back Chronic Clinical Trial

Official title:
A Randomized Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

Clinical Trial Description

A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01081912
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date March 2010
Completion date October 2011
View Details
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