Clinical trial · Interventional
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
NCT01842893CI-TRIAL-00010188ETHYFYLcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breakthrough Pain | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Ethypharm | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fentanyl / Placebo
- 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)
- interventionNames
- Drug: Fentanyl Ethypharm
Primary outcomes (1)
- measure
- Summed Pain Intensity Difference at 30 minutes (SPID30).
- timeFrame
- 30 minutes post dose
Secondary outcomes (7)
- measure
- SPID at 3, 6, 10, 15 and 60 minutes post-dosing
- timeFrame
- 3, 6, 10, 15 and 60 minutes post-dosing
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNovotna 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 24508417