NCT01428583

Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Conditions

• Chronic Noncancer Pain

Interventions

Type	Name	Description
DRUG	oxycodone HCl and naltrexone HCl extended-release capsules	Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-09-05
• Last updated: 2016-11-21
• Results posted: 2016-11-21

Locations

32 sites across 1 country: United States