NCT01008553

A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome

A Verification Study of JNS020QD in Patients With Post-herpetic Neuralgia, Complex Regional Pain Syndrome (CRPS) or Postoperative Pain Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).

Detailed description

This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with post-herpetic neuralgia (intense, typically intermittent pain along the course of a nerve caused by the varicella zoster virus), complex regional pain syndrome or post-operative pain syndrome. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 22, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram/hour or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.

Conditions

• Postherpetic Neuralgia
• Complex Regional Pain Syndromes (CRPS)
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Fentanyl	One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.
DRUG	Placebo	Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-11-06
• Last updated: 2013-07-25
• Results posted: 2013-07-25

Locations

79 sites across 1 country: Japan