- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842893
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
-
-
-
Prague, Czech Republic
- Pain Care Units
-
-
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:
- 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
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)
|
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
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.
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
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on Fentanyl Ethypharm
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)CompletedPeer Review, ResearchUnited States
-
Alexza Pharmaceuticals, Inc.Completed
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
University of Texas Southwestern Medical CenterCompletedPregnancyUnited States
-
Samuel Lunenfeld Research Institute, Mount Sinai...Terminated
-
Janssen Research & Development, LLCCompleted
-
University of PatrasUnknownStillborn Caesarean SectionGreece
-
Johns Hopkins UniversityCompletedIntracranial SurgeryUnited States
-
Janssen Korea, Ltd., KoreaCompletedChronic PainKorea, Republic of