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

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ClinicalTrials.gov Identifier: NCT01902524
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Fentanyl-TTS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
Study Start Date : October 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Fentanyl-TTS
Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
Drug: Fentanyl-TTS
All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
Other Name: fentanyl




Primary Outcome Measures :
  1. The change in pain intensity [ Time Frame: Baseline, 12 weeks ]
    The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.


Secondary Outcome Measures :
  1. Daily dose of prescribed medication [ Time Frame: 12 weeks ]
    Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.

  2. Change in functionality [ Time Frame: 12 weeks ]
    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).

  3. Change in sleep [ Time Frame: 12 weeks ]
    Change in the frequency of waking up due to pain during the sleep.

  4. Satisfaction in study medication [ Time Frame: 12 weeks ]
    Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.

  5. The number of participants reporting adverse events (AEs) [ Time Frame: 12 weeks ]
    All AEs during the study period will be reported.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902524


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 140-702
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trials Janssen Korea, Ltd., Korea

Additional Information:
Publications of Results:
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01902524     History of Changes
Other Study ID Numbers: CR002155
FEN-KOR-10 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Janssen Korea, Ltd., Korea:
Chronic Pain
Fentanyl-TTS
Fentanyl Patch
Transdermal
Non-cancer Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics