Trial | NCT01842893  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fentanyl ...

  • Study Participants

    91
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.
Study Started
Nov 30
2011
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
May 03
2013
Estimate

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)

Fentanyl / Placebo Experimental

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)

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
No Results Posted