Phase 3 N=5 Treatment

Long-term Extension Study of BEMA™ Fentanyl

Respiratory Depression

Bottom Line

View on ClinicalTrials.gov: NCT00696137 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2018

Primary outcome: Primary: Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported. — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BEMA Fentanyl (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: BioDelivery Sciences International
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.	—	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

previously qualified for and participated in study FEN-202 for at least 2 weeks,
wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria

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
there is evidence of improper use of the study drug.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00696137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.