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Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

Chronic Pain Clinical Trial

Official title:
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Pain Due to Osteoarthritis of the Knee Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

Clinical Trial Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during defined periods of evaluation.

Clinical Trial Description

The trial will last up to 13 weeks for each subject and includes:

- One week of observation under previous analgesic treatment.

- Twelve weeks of treatment with tapentadol hydrochloride PR. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00982280
Study type Interventional
Source Grünenthal GmbH
Contact
Status Terminated
Phase Phase 3
Start date September 2009
Completion date August 2010
View Details
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