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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00283842
• Other study ID #: 3151A5-322
• Status: Terminated
• Phase: Phase 3
• First received: January 26, 2006
• Last updated: October 20, 2011
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 408
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• DVS SR

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Pain Severity Score From Baseline to 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.	Baseline and 13 weeks	No
Secondary	Number of Patients With =50% Reduction in Mean Pain Severity Score.	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.	Baseline and 13 weeks	No