Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
- Registration Number
- NCT01842893
- Lead Sponsor
- Ethypharm
- Brief Summary
The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fentanyl / Placebo Fentanyl Ethypharm After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
- Primary Outcome Measures
Name Time Method Summed Pain Intensity Difference at 30 minutes (SPID30). 30 minutes post dose
- Secondary Outcome Measures
Name Time Method Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing 3, 6, 10, 15, 30 and 60 minutes after dosing Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing 3, 6, 10, 15, 30 and 60 minutes after dosing The proportion of episodes of BTP that required rescue medication 15 and 30 minutes post dose the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores 15 and 30 minutes post dose SPID at 3, 6, 10, 15 and 60 minutes post-dosing 3, 6, 10, 15 and 60 minutes post-dosing Recording of safety data During all the study duration, an expected average of 8 weeks Adverse events, vital signs, urinary pregnancy test
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive) 15 and 30 minutes post dose
Trial Locations
- Locations (1)
Pain Care Units
🇨🇿Prague, Czech Republic