Clinical trial · Interventional
Long-term Extension Study of BEMA™ Fentanyl
Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
NCT00696137CI-TRIAL-00040790completedPhase 3Results postedClinicalTrials.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)
This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.
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 |
|---|---|---|---|
| Respiratory Depression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEMA Fentanyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BEMA Fentanyl
- description
- BEMA Fentanyl
- interventionNames
- Drug: BEMA Fentanyl
Primary outcomes (1)
- measure
- Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
- timeFrame
- 3 years
- description
- Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. previously qualified for and participated in study FEN-202 for at least 2 weeks, 2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and 3. provide signed informed consent at screening prior to any study procedures. Exclusion Criteria: 1. they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or 2. there is evidence of improper use of the study drug.
References
Publications (0)
Data not yet available
No reference posted for this study.