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

May 2, 2013 updated by: Ethypharm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Main 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
Time Frame: 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)
Time Frame: 15 and 30 minutes post dose
15 and 30 minutes post dose
Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
Time Frame: 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
Time Frame: 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
Time Frame: 15 and 30 minutes post dose
15 and 30 minutes post dose
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Time Frame: 15 and 30 minutes post dose
15 and 30 minutes post dose
Recording of safety data
Time Frame: During all the study duration, an expected average of 8 weeks
Adverse events, vital signs, urinary pregnancy test
During all the study duration, an expected average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethypharm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYL/24019/008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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