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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01842893

Acronym

ETHYFYL

Enrollment

Registered

2013-04-30

Start date

2011-11-30

Completion date

2012-07-31

Last updated

2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breakthrough Pain, Cancer

Keywords

fentanyl, breakthrough pain, opioid treated cancer patients

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.

Interventions

DRUGFentanyl 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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Summed Pain Intensity Difference at 30 minutes (SPID30).	30 minutes post dose

Secondary

Measure	Time frame	Description
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	—
SPID at 3, 6, 10, 15 and 60 minutes post-dosing	3, 6, 10, 15 and 60 minutes post-dosing	—
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores	15 and 30 minutes post dose	—
Recording of safety data	During all the study duration, an expected average of 8 weeks	Adverse events, vital signs, urinary pregnancy test
The proportion of episodes of BTP that required rescue medication	15 and 30 minutes post dose	—

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026