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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902524
• Other study ID #: CR002155
• Secondary ID: FEN-KOR-10
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2013
• Last updated: August 27, 2014
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: August 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Fentanyl-TTS
All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Daily dose of prescribed medication	Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.	12 weeks	No
Secondary	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	No
Secondary	Change in sleep	Change in the frequency of waking up due to pain during the sleep.	12 weeks	No
Secondary	Satisfaction in study medication	Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.	12 weeks	No
Secondary	The number of participants reporting adverse events (AEs)	All AEs during the study period will be reported.	12 weeks	Yes

External Links

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