Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain
August 27, 2014 updated by: Janssen Korea, Ltd., Korea
Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 140-702
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Fentanyl-TTS
Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
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All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change in pain intensity
Time Frame: Baseline, 12 weeks
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The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
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Baseline, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Daily dose of prescribed medication
Time Frame: 12 weeks
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Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.
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12 weeks
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Change in functionality
Time Frame: 12 weeks
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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).
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12 weeks
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Change in sleep
Time Frame: 12 weeks
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Change in the frequency of waking up due to pain during the sleep.
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12 weeks
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Satisfaction in study medication
Time Frame: 12 weeks
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Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.
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12 weeks
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The number of participants reporting adverse events (AEs)
Time Frame: 12 weeks
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All AEs during the study period will be reported.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen Korea, Ltd., Korea Clinical Trials, Janssen Korea, Ltd., Korea
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
July 15, 2013
First Submitted That Met QC Criteria
July 15, 2013
First Posted (Estimate)
July 18, 2013
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002155
- FEN-KOR-10 (Other Identifier: Janssen Korea, Ltd., Korea)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.