Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
ETHYFYL
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
1 other identifier
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedMay 3, 2013
April 1, 2013
8 months
April 18, 2013
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summed Pain Intensity Difference at 30 minutes (SPID30).
30 minutes post dose
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Fentanyl / Placebo
EXPERIMENTALAfter 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
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethypharmlead
Study Sites (1)
Pain Care Units
Prague, Czechia
Related Publications (1)
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.
PMID: 24508417DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 30, 2013
Study Start
November 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 3, 2013
Record last verified: 2013-04