Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component
- Conditions
- ernstig chronische lage rugpijn met een neuropatische componentneuropatic pain and low back pain
- Registration Number
- NL-OMON36404
- Lead Sponsor
- Grunenthal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Signed Informed consent. Male of female older then 18 years with severe chronic low back pain with a neuropathic component, for at least 3 months. Using a step II of III analgetic for at least 2 weeks before enrollment. When treatment with step II analgetics the pain must be 5 or higher for the last 3 days before enrollment. When using a step I analgetic a pain of 6 or higher must be scored.Woman of childbearing potential must be using birthcontrol, must have a negative pregnancy test and no breastfeeding allowed.
alcohol or drug abuse, presence of systemic or local infections, hypersensitivity of tapentadol, participation in another trial, use of MAO inhibitors within 14 days before enrollment, non-stable dosing SSRI's. Presence of clinically significant disease of laboratory findings that according to the investigator effect safety and efficacy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint<br /><br>Comparison of the average of 3 days pain intensity score (NRS 3) at the<br /><br>Baseline Visit versus the average NRS 3 pain intensity score at the Final<br /><br>Evaluation Visit of treatment arm 1 (increasing doses of tapentadol PR) and<br /><br>treatment arm 2 (combination of tapentadol PR and pregabalin). </p><br>
- Secondary Outcome Measures
Name Time Method