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Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

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NCT00283842

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Mesa, Arizona, 85210 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Neuropathies, Pain
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

- Diabetes type 1 or 2

- Painful symptoms of diabetic neuropathy in the lower extremities extremities for at
least 6 months

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Major Depression

- Uncontrolled diabetes

NCT00283842
Pfizer
Terminated
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

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Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Neuropathies
  • Pain
  • Drug: DVS SR
  • Drug: Placebo
  • Experimental: desvenlafaxine succinate sustained-release (DVS SR) 50mg
    Intervention: Drug: DVS SR
  • Experimental: desvenlafaxine succinate sustained-release (DVS SR) 100mg
    Intervention: Drug: DVS SR
  • Experimental: desvenlafaxine succinate sustained-release (DVS SR) 200mg
    Intervention: Drug: DVS SR
  • Experimental: desvenlafaxine succinate sustained-release (DVS SR) 400mg
    Intervention: Drug: DVS SR
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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
408
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes type 1 or 2
  • Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months

Exclusion Criteria:

  • Major Depression
  • Uncontrolled diabetes
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00283842
3151A5-322
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
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
October 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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