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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Fentanyl-TTS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl-TTS<br>Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2. | Drug: Fentanyl-TTS<br>* All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.<br>* Other names: fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily dose of prescribed medication | Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks. | 12 weeks | 
| Change in functionality | 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). | 12 weeks | 
| Change in sleep | Change in the frequency of waking up due to pain during the sleep. | 12 weeks | 
| Satisfaction in study medication | Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits. | 12 weeks | 
| The number of participants reporting adverse events (AEs) | All AEs during the study period will be reported. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Fentanyl-TTS, Fentanyl Patch, Transdermal, Non-cancer Pain