Trial Information
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Inclusion Criteria
Inclusion criteria:
1. Written informed consent
2. Malignant solid tumor or a hematological malignancy causing cancer-related pain
3. Background opioid treatment at a stable dose for at least a week
4. One to four episodes of breakthrough pain per day
Main exclusion criteria:
1. Hypersensitivity to fentanyl or to any of the excipients
2. Intrathecal opioids
3. Recent history of substance abuse
4. Recent or planned therapy that would alter pain
5. Moderate or severe hepatic or renal disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Summed Pain Intensity Difference at 30 minutes (SPID30).
Outcome Time Frame:
30 minutes post dose
Safety Issue:
No
Authority:
Czech Republic: Ethics Committee
Study ID:
FYL/24019/008
NCT ID:
NCT01842893
Start Date:
November 2011
Completion Date:
July 2012
Related Keywords:
- Breakthrough Pain
- Cancer
- fentanyl
- breakthrough pain
- opioid treated cancer patients