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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-11-30

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.

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fentanyl-TTS

Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.

Group Type EXPERIMENTAL

Fentanyl-TTS

Intervention Type DRUG

All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.

Interventions

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Fentanyl-TTS

All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.

Intervention Type DRUG

Other Intervention Names

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fentanyl

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No