Clinical trial NCT01902524: Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain
Official title: Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Chronic Pain
Fentanyl-TTS
Fentanyl Patch
Transdermal
Non-cancer Pain
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in pain intensity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Daily dose of prescribed medication
timeFrame: 12 weeks
measure: Change in functionality
timeFrame: 12 weeks
measure: Change in sleep
timeFrame: 12 weeks
measure: Satisfaction in study medication
timeFrame: 12 weeks
measure: The number of participants reporting adverse events (AEs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Park JH, Kim JH, Yun SC, Roh SW, Rhim SC, Kim CJ, Jeon SR. Evaluation of efficacy and safety of fentanyl transdermal patch (Durogesic D-TRANS) in chronic pain. Acta Neurochir (Wien). 2011 Jan;153(1):181-90. doi: 10.1007/s00701-010-0785-4. Epub 2010 Sep 7.