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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Fentanyl-TTS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
Other Name: fentanyl
- 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.
- 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.
- 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).
- Change in sleep [ Time Frame: 12 weeks ]Change in the frequency of waking up due to pain during the sleep.
- Satisfaction in study medication [ Time Frame: 12 weeks ]Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.
- The number of participants reporting adverse events (AEs) [ Time Frame: 12 weeks ]All AEs during the study period will be reported.
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
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 140-702|
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trials||Janssen Korea, Ltd., Korea|