NL-OMON36404
Completed
Phase 3
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 - n.a.
Grunenthal0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ernstig chronische lage rugpijn met een neuropatische component
- Sponsor
- Grunenthal
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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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 componentEUCTR2010-019998-14-DEGrünenthal GmbH800