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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DVS SR Open Label<br>Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level. | Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)<br> <br> * Other names: DVS SR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). | 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. | Baseline and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Peripheral Neuropathy