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

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Fentanyl-TTS

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Fentanyl-TTS, Fentanyl Patch, Transdermal, Non-cancer Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fentanyl-TTS

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Daily dose of prescribed medication

Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 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).

Change in sleep

Change in the frequency of waking up due to pain during the sleep.

Satisfaction in study medication

Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.

The number of participants reporting adverse events (AEs)

All AEs during the study period will be reported.

Full Information

NCT ID

NCT01902524

First Posted

July 15, 2013

Last Updated

August 27, 2014

Sponsor

Janssen Korea, Ltd., Korea

1. Study Identification

Unique Protocol Identification Number

NCT01902524

Brief Title

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

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Korea, Ltd., Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Chronic Pain, Fentanyl-TTS, Fentanyl Patch, Transdermal, Non-cancer Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl-TTS

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fentanyl-TTS

Other Intervention Name(s)

fentanyl

Intervention Description

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

Primary Outcome Measure Information:

Title

The change in pain intensity

Description

The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Daily dose of prescribed medication

Description

Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.

Time Frame

12 weeks

Title

Change in functionality

Description

Time Frame

12 weeks

Title

Change in sleep

Description

Change in the frequency of waking up due to pain during the sleep.

Time Frame

12 weeks

Title

Satisfaction in study medication

Description

Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.

Time Frame

12 weeks

Title

The number of participants reporting adverse events (AEs)

Description

All AEs during the study period will be reported.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Korea, Ltd., Korea Clinical Trials

Organizational Affiliation

Janssen Korea, Ltd., Korea

Official's Role

Study Director

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

140-702

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

20821238

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.

Results Reference

result

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1148&filename=CR002155_CSR.pdf

Description

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

Learn more about this trial

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

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