|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00696137 |
|
Date of registration:
|
10/06/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Long-term Extension Study of BEMA™ Fentanyl
|
|
Scientific title:
|
Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl |
|
Date of first enrolment:
|
June 2008 |
|
Target sample size:
|
5 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00696137 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Contacts
|
|
Name:
|
David Blum, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
BioDelivery Sciences International |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Respiratory Depression
|
|
Intervention(s)
|
|
Drug: BEMA Fentanyl
|
|
Primary Outcome(s)
|
|
Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
[Time Frame: 3 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|