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

Phase 4

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Fentanyl-TTS

• Registration Number: NCT01902524
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief 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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-18
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• spine related and extremity pain lasting for 3 months or longer
• pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
• good overall health condition based on the medical history and clinical laboratory tests
• participants using appropriate contraception in case of childbearing potential during the study period.

Exclusion Criteria

• history of hypersensitive reaction to narcotic analgesics
• history of narcotic abuse
• serious psychotic disorder
• unable to use transdermal analgesics due to a dermatological condition
• history of CO2 retention (e.g., chronic obstructive pulmonary disease)
• surgery in the area with pain within 7 days prior to initiation of the clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fentanyl-TTS	Fentanyl-TTS	Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.

Primary Outcome Measures

Name	Time	Method
The change in pain intensity	Baseline, 12 weeks	The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.

Secondary Outcome Measures

Name	Time	Method
Change in sleep	12 weeks	Change in the frequency of waking up due to pain during the sleep.
Satisfaction in study medication	12 weeks	Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.
Daily dose of prescribed medication	12 weeks	Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.
Change in functionality	12 weeks	Satisfaction in functionality by participants evaluated at day 0 and after 1, 4, 8 and 12 weeks of treatment, measured as improvements in change of scores from 0 (not disturbing) to 10 (completely disturbing).
The number of participants reporting adverse events (AEs)	12 weeks	All AEs during the study period will be reported.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of