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A 9-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.
Details
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 237 |
| Start date | 2006-07 |
| Completion | 2009-01 |
Conditions
- Diabetic Neuropathy, Painful
Interventions
- Desvenlafaxine Succinate Sustained-Release (DVS SR)
Primary outcomes
- Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). — Baseline and 9 months
The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.