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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 May 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
A 9-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Other Name: DVS SR
DVS SR Open Label
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Allen R, Sharma U, Barlas S. Clinical experience with desvenlafaxine in treatment of pain associated with diabetic peripheral neuropathy. J Pain Res. 2014 Jun 23;7:339-51. doi: 10.2147/JPR.S55682. eCollection 2014.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
237
January 2009
January 2009   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01050218
3151A5-325
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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