Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

Phase 3

Terminated

• Conditions: Diabetic Neuropathies; Pain
• Interventions: Drug: DVS SR; Drug: Placebo

• Registration Number: NCT00283842
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-30
• Study Start: 2006-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-06-30
• Results First Submitted QC: 2009-06-30
• Results First Posted: 2009-08-13
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
desvenlafaxine succinate sustained-release (DVS SR) 50mg	DVS SR	-
desvenlafaxine succinate sustained-release (DVS SR) 100mg	DVS SR	-
desvenlafaxine succinate sustained-release (DVS SR) 200mg	DVS SR	-
desvenlafaxine succinate sustained-release (DVS SR) 400mg	DVS SR	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Pain Severity Score From Baseline to 13 Weeks	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 Outcome Measures

Name	Time	Method
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.	Baseline and 13 weeks	Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.