Clinical trial · Interventional
Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain
Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
NCT01902524CI-TRIAL-00015490completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl-TTS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fentanyl-TTS
- description
- Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2.
- interventionNames
- Drug: Fentanyl-TTS
Primary outcomes (1)
- measure
- The change in pain intensity
- timeFrame
- Baseline, 12 weeks
- description
- The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
Secondary outcomes (5)
- measure
- Daily dose of prescribed medication
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTPark 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. PMID 20821238