Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Cancer Clinical Trial

— ETHYFYL  

Official title:

Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842893
• Other study ID #: FYL/24019/008
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2013
• Last updated: May 2, 2013
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Ethypharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer

Intervention

Drug:
• Fentanyl 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)

Locations

Country	Name	City	State
Czech Republic	Pain Care Units	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Ethypharm

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed Pain Intensity Difference at 30 minutes (SPID30).		30 minutes post dose	No
Secondary	SPID at 3, 6, 10, 15 and 60 minutes post-dosing		3, 6, 10, 15 and 60 minutes post-dosing	No
Secondary	SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)		15 and 30 minutes post dose	No
Secondary	Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing		3, 6, 10, 15, 30 and 60 minutes after dosing	No
Secondary	Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing		3, 6, 10, 15, 30 and 60 minutes after dosing	No
Secondary	The proportion of episodes of BTP that required rescue medication		15 and 30 minutes post dose	No
Secondary	the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores		15 and 30 minutes post dose	No
Secondary	Recording of safety data	Adverse events, vital signs, urinary pregnancy test	During all the study duration, an expected average of 8 weeks	Yes