NCT00283842
Terminated
Phase 3
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Wyeth is now a wholly owned subsidiary of Pfizer0 sites408 target enrollmentMarch 2006
Overview
- Phase
- Phase 3
- Intervention
- DVS SR
- Conditions
- Diabetic Neuropathies
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 408
- Primary Endpoint
- Change in Mean Pain Severity Score From Baseline to 13 Weeks
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetes type 1 or 2
- •Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
Exclusion Criteria
- •Major Depression
- •Uncontrolled diabetes
Arms & Interventions
desvenlafaxine succinate sustained-release (DVS SR) 50mg
Intervention: DVS SR
desvenlafaxine succinate sustained-release (DVS SR) 100mg
Intervention: DVS SR
desvenlafaxine succinate sustained-release (DVS SR) 200mg
Intervention: DVS SR
desvenlafaxine succinate sustained-release (DVS SR) 400mg
Intervention: DVS SR
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Time Frame: Baseline and 13 weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Secondary Outcomes
- Number of Patients With ≥50% Reduction in Mean Pain Severity Score.(Baseline and 13 weeks)
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