Clinical trial · Interventional
Fentanyl Matrix in Lung Cancer Pain
Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
NCT01060137CI-TRIAL-00003109completedPhase 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 evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fentanyl matrix | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- description
- fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment
- interventionNames
- Drug: fentanyl matrix
Primary outcomes (1)
- measure
- Patient's satisfaction with pain treatment as measured by 5-point verbal scale
- timeFrame
- Day 1, 8 and 22
Secondary outcomes (4)
- measure
- Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
- timeFrame
- Day 1 (visit 1) and 22 (visit 3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed lung cancer, who complain of cancer pain * Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day * Patients who are able to communicate with the investigator about his/her pain * Patients who use proper contraceptives during the study period if they are women of childbearing potential * Patients whose life expectancy is 3 months or longer * Patients who have signed an informed consent form Exclusion Criteria: * Patients participating in other clinical trials * Patients with a history of hypersensitivity to opioid analgesics * Patients with a history of drug abuse * Patients who are unable to use a transdermal product due to skin disease * Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease) * Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study * Patient who are pregnant or are of childbearing potential and not using contraceptives
References
Publications (0)
Data not yet available
No reference posted for this study.