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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

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.

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Detailed Description

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Conditions

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Breakthrough Pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fentanyl / Placebo

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)

Group Type EXPERIMENTAL

Fentanyl Ethypharm

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No