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

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Wyeth

Status and phase

Terminated
Phase 3

Conditions

Diabetic Neuropathy, Painful

Treatments

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01050218
3151A5-325

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

237 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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