Long-term Extension Study of BEMA™ Fentanyl
CompletedPhase 3NCT00696137
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
- Conditions
- Respiratory Depression
- Interventions
- Drug: BEMA Fentanyl
- Sponsor
- BioDelivery Sciences International
- Start date
- 2008-06
- Primary completion
- 2009-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00696137