NCT00983073

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (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 in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. 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 (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Conditions

• Chronic Pain
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Tapentadol	Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 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: 2010-06-01
• Completion: 2010-09-01
• First posted: 2009-09-23
• Last updated: 2019-10-21
• Results posted: 2012-03-29

Locations

24 sites across 5 countries: France, Germany, Poland, Spain, United Kingdom