Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain. Clinical Trial

Official title: A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.

Status Completed

Clinical Trial Summary

Primary objectives:

• To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment

• To assess the safety of FITpatch compared to standard opioid treatment

Secondary objectives:

• To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment

• To assess Quality of life reported with FITpatch compared to standard opioid treatment

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

• NCT number: NCT00279344
• Study type: Interventional
• Source: Nycomed
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Completion date: August 2007