Clinical trial · Interventional
Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement
Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial
NCT05053308CI-TRIAL-00068638withdrawnN/AClinicalTrials.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): The supply of IP is disrupted
Summary
Brief summary (as posted)
Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.
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 |
|---|---|---|---|
| Breakthrough Pain | — | UNRESOLVED | — |
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Infusion | Drug | — | UNRESOLVED |
| Sublingual Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IV PCA (proportional dosage)
- description
- Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME \* 15%
- interventionNames
- Drug: Intravenous Infusion
- type
- EXPERIMENTAL
- label
- SL-FTN (equivalent dose for PCA bolus)
- description
- Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
- interventionNames
- Drug: Sublingual Tablet
Primary outcomes (1)
- measure
- Change in 11-point scale NRS pain score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 19-80 * Cancer pain * Admission for the control of cancer pain or consultation for the treatment of cancer pain * Stable vital sign * ECOG status ≤ 3 for more than 1 or 2 months * Opioid-tolerant state * No history of using sublingual fentanyl Exclusion Criteria: * Noncancer pain * Opioid naive * baseline NRS pain score\> 4 * Current using sublingual fentanyl * Difficult to assess cancer pain * no evidence of disease(cancer) * Planned surgical resection of cancer * Allergy to fentanyl * Severe renal and/or liver function * Severe respiratory depression or uncontrolled COPD
References
Publications (0)
Data not yet available
No reference posted for this study.