Clinical trial · Interventional
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
NCT00105937CI-TRIAL-00007292completedPhase 3ClinicalTrials.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 long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OraVescent fentanyl citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tolerability and safety of OraVescent fentanyl when used long-term
Secondary outcomes (2)
- measure
- Assess the effectiveness of OraVescent fentanyl
- measure
- Assess the development of incremental tolerance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 18-80 years of age * Average of 1-4 breakthrough pain episodes per day * Opioid tolerant * Histologically documented diagnosis of a malignant solid tumor or hematological malignancy Exclusion Criteria: * Primary breakthrough pain is not related to cancer in any way * Opioid or fentanyl intolerance * Chronic obstructive pulmonary disease (COPD) or heart disease * Sleep apnea or active brain metastases with increased cranial pressure
References
Publications (0)
Data not yet available
No reference posted for this study.