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
2 other identifiers
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 chronic-pain
Started Oct 2005
Shorter than P25 for phase_4 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 15, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedAugust 28, 2014
August 1, 2014
1.1 years
July 15, 2013
August 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in pain intensity
The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
Baseline, 12 weeks
Secondary Outcomes (5)
Daily dose of prescribed medication
12 weeks
Change in functionality
12 weeks
Change in sleep
12 weeks
Satisfaction in study medication
12 weeks
The number of participants reporting adverse events (AEs)
12 weeks
Study Arms (1)
Fentanyl-TTS
EXPERIMENTALStudy drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
Interventions
All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 140-702, South Korea
Related Publications (1)
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.
PMID: 20821238RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trials
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2013
First Posted
July 18, 2013
Study Start
October 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
August 28, 2014
Record last verified: 2014-08