NCT00195728

Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain

An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.

Conditions

• Moderate to Severe Chronic, Non-malignant Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone/Acetaminophen on Extended Release	2 tablets twice daily

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-20
• Last updated: 2011-01-19

Locations

76 sites across 1 country: United States