NCT01902524

Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain

Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.

Detailed description

This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (TTS) Durogesic® D-Trans in patients with non-cancer pain. The patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). The study will be conducted for 12 weeks. The efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. All participants will use the patch at least once during the study. The drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. The overall safety will be assessed based on the adverse events reporting.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Fentanyl-TTS	All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2013-07-18
• Last updated: 2014-08-28

Locations

1 site across 1 country: South Korea