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

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).

NCT01050218
Pfizer
Terminated
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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