Clinical trial · Interventional
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
NCT01060124CI-TRIAL-00014366completedPhase 4Results postedClinicalTrials.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 evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.
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 |
|---|---|---|---|
| Pain; Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl D-trans | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transdermal Therapeutic System (TTS)-Fentanyl D-trans
- interventionNames
- Drug: Fentanyl D-trans
Primary outcomes (1)
- measure
- Percentage of Participants Satisfied With Pain Treatment
- timeFrame
- Day 29
- description
- Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.
Secondary outcomes (1)
- measure
- Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans
- timeFrame
- Day 1 and Day 29
- description
- Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Participants who complains of cancer pain * Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours * Participants with an estimated life expectancy of at least 2 months * Participants who are able to communicate with the investigator * Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period Exclusion Criteria: * Participants participating in another clinical trial * Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse * Participants who have active skin disease, avoiding application of the transdermal system * Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease) * Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period
References
Publications (0)
Data not yet available
No reference posted for this study.