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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Conditions
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Breakthrough Pain, Cancer

Intervention / Treatment
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* Drug: Fentanyl Ethypharm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl / Placebo<br>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) | Drug: Fentanyl Ethypharm<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Pain Intensity Difference at 30 minutes (SPID30). |  | 30 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID at 3, 6, 10, 15 and 60 minutes post-dosing |  | 3, 6, 10, 15 and 60 minutes post-dosing | 
| SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive) |  | 15 and 30 minutes post dose | 
| 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 | 
| Recording of safety data | Adverse events, vital signs, urinary pregnancy test | During all the study duration, an expected average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, breakthrough pain, opioid treated cancer patients