Clinical trial · Interventional
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fentanyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.
Secondary outcomes (1)
- measure
- Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Less than a month of opioid treatment over the past 3 months * Proven cancer and chronic stable, cancer-related pain * Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit * A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator Exclusion Criteria: * Liver or kidney problems * Previous heart, lung or nervous disorders * Allergy to fentanyl * Skin condition that might interfere with absorption of the fentanyl through the skin * Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study * History of substance abuse
References
Publications (0)
Data not yet available