NCT00986258

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain 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 Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 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 subjects suffering from severe chronic low back pain (LBP) 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 prolonged release treatment during defined periods of evaluation.

Conditions

• Pain
• Chronic Pain
• Low Back Pain
• Neuropathic Pain
• Nociceptive Pain

Interventions

Type	Name	Description
DRUG	Tapentadol Prolonged Release	Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows: * if less than 100 mg morphine equivalent start with 50 mg tapentadol PR; * if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR; * if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR. Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.

Timeline

• Start date: 2009-10-30
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-09-29
• Last updated: 2019-01-09
• Results posted: 2013-03-18

Locations

27 sites across 8 countries: Belgium, Czechia, France, Germany, Netherlands, Poland, Spain, Switzerland