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A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer

Chronic Pain Clinical Trial

Official title:
A Multicenter, Open-label, Randomized, Parallel Group Study to Compare the Efficacy and Safety of Sufentanil Transdermal System (TDS) With Sustained-Release Morphine Sulfate in Patients With Chronic Pain Due to Cancer

Clinical Trial Summary

The study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer.

Clinical Trial Description

The primary objective of this study is to compare the consumption, in milligrams, of rescue analgesia (normal release morphine sulfate tablets) after the administration of sufentanil TDS or sustained release morphine sulfate.

The secondary efficacy objectives of this study are to evaluate:

- Pharmacokinetic data

- Adverse events ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00943566
Study type Interventional
Source Labtec GmbH
Contact
Status Withdrawn
Phase Phase 2
Start date January 2010
Completion date February 2011
View Details
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