NCT01452529

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 905 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone bitartrate q24h film-coated tablets	Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
DRUG	Placebo to match hydrocodone bitartrate q24h tablets	Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2011-10-17
• Last updated: 2020-03-10
• Results posted: 2014-12-04

Locations

102 sites across 1 country: United States