Clinical trial · Interventional
Conversion From Fast Acting Oral Opioids to Abstral®
Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
NCT01315886CI-TRIAL-00026795terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulties
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
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 |
|---|---|---|---|
| SL fentanyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SL Fentanyl conversion
- description
- * Baseline period: 7-15 episodes of breakthrough cancer pain treated with prior IR opioid medication * Treatment period: Conversion to SL Fentanyl at a Fentanyl:Prior opioid conversion factor of 1:50 (using the estimated Morphine Sulphate Equivalent dose for the prior opioid). SL Fentanyl use was followed for 8-15 episodes of breakthrough cancer pain. SL Fentanyl dose could be titrated between episodes.
- interventionNames
- Drug: SL fentanyl
Primary outcomes (1)
- measure
- Response rate in patients converted to SL fentanyl.
- timeFrame
- 30 minutes post dose
- description
- A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent obtained. * 18 years or older, of both genders. * Opioid tolerant patients * Estimated frequency of BTcP 0.5-4 times a day. Exclusion Criteria: * Treatment with SL fentanyl within two weeks prior to screening. * Recent or planned therapy that would alter pain or responses to analgesics. * Treatment with monoamine oxidase inhibitor \< 14 days before or concurrent with SL fentanyl treatment. * Significantly reduced liver and/or kidney function. * Significant prior history of substance abuse. * Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.
References
Publications (0)
Data not yet available
No reference posted for this study.