Back to resultsEfficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer (ETHYFYL)
Primary Purpose
Breakthrough Pain, Cancer
Status
Completed
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
Fentanyl Ethypharm
Sponsored by
About this trial
This is an interventional treatment trial for Breakthrough Pain focused on measuring fentanyl, breakthrough pain, opioid treated cancer patients
Eligibility Criteria
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
Sites / Locations
- Pain Care Units
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fentanyl / Placebo
Arm Description
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)
Outcomes
Primary Outcome Measures
Summed Pain Intensity Difference at 30 minutes (SPID30).
Secondary Outcome Measures
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing
The proportion of episodes of BTP that required rescue medication
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Recording of safety data
Adverse events, vital signs, urinary pregnancy test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01842893
Brief Title
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Acronym
ETHYFYL
Official Title
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethypharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Pain, Cancer
Keywords
fentanyl, breakthrough pain, opioid treated cancer patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl / Placebo
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Fentanyl Ethypharm
Intervention Description
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 Measure Information:
Title
Summed Pain Intensity Difference at 30 minutes (SPID30).
Time Frame
30 minutes post dose
Secondary Outcome Measure Information:
Title
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
Time Frame
3, 6, 10, 15 and 60 minutes post-dosing
Title
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
Time Frame
15 and 30 minutes post dose
Title
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
Title
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
Title
The proportion of episodes of BTP that required rescue medication
Time Frame
15 and 30 minutes post dose
Title
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Time Frame
15 and 30 minutes post dose
Title
Recording of safety data
Description
Adverse events, vital signs, urinary pregnancy test
Time Frame
During all the study duration, an expected average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pain Care Units
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
24508417
Citation
Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
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