Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Phase 3

Terminated

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

• Registration Number: NCT01050218
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Results First Submitted: 2010-01-29
• Results First Submitted QC: 2010-04-20
• Results First Posted: 2010-05-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Outpatients who have completed double-blind treatment in study 322 (NCT01050218) for DPN. Subjects must have completed all scheduled evaluations, with no major protocol violations and no events that, in the opinion of the investigator, would preclude the subject's entry into the long-term open-label study.
• Women of childbearing potential must have a negative serum pregnancy test on day 91 of the short-term study. A woman of childbearing potential is one who is biologically capable of becoming pregnant. "Biologically capable" includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study who are biologically capable of becoming pregnant must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. Medically acceptable forms of contraception include oral contraceptives, transdermal, injectable, or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm.

Exclusion Criteria

• Presence of any new and/or clinically important medical condition that might compromise subject safety (including, but not limited to, significant changes in glycemic control).
• Pregnancy, lactation, or plans to become pregnant during the study.
• Use of prohibited treatments.
• Meets any of the exclusion criteria listed for study 322 (NCT01050218).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DVS SR Open Label	Desvenlafaxine Succinate Sustained-Release (DVS SR)	Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.

Primary Outcome Measures

Name	Time	Method
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.