NCT00982280

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.

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Pain
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Tapentadol PR	Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day. Maintenance Period: Participants continuing on the dose established in the previous period.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2009-09-23
• Last updated: 2019-10-18
• Results posted: 2011-12-14

Locations

24 sites across 6 countries: Australia, Denmark, Germany, Poland, Spain, United Kingdom