Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Phase 3

Completed

• Conditions: Cancer; Breakthrough Pain
• Interventions: Drug: Fentanyl Ethypharm

• 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

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03

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