Status:
COMPLETED
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Lead Sponsor:
Ethypharm
Conditions:
Breakthrough Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Written informed consent
- Malignant solid tumor or a hematological malignancy causing cancer-related pain
- Background opioid treatment at a stable dose for at least a week
- One to four episodes of breakthrough pain per day
- Main exclusion criteria:
- Hypersensitivity to fentanyl or to any of the excipients
- Intrathecal opioids
- Recent history of substance abuse
- Recent or planned therapy that would alter pain
- Moderate or severe hepatic or renal disease
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01842893
Start Date
November 1 2011
End Date
July 1 2012
Last Update
May 3 2013
Active Locations (1)
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1
Pain Care Units
Prague, Czechia