NCT01559701

Long-term Safety of PF-00345439 (Oxycodone)

A Long-Term, Open-Label, Safety Study Of PTI-821 In Patients With Moderate To Severe Chronic Low Back Pain Or With Moderate To Severe Chronic Pain Due To Osteoarthritis Of The Hip Or Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 823 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis

Detailed description

This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	PF-00345439	5-80 mg twice-a-day for 12 months

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2012-03-21
• Last updated: 2015-09-11