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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 February 13, 2020
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FOR MORE INFORMATION
Study Location
Mesa, Arizona, 85210 United States
See other locations
Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Neuropathies
  • Pain
Intervention  ICMJE
  • Drug: DVS SR
  • Drug: Placebo
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 30, 2009) 		408
Original Enrollment  ICMJE
 (submitted: January 26, 2006) 		450
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283842
Other Study ID Numbers  ICMJE 3151A5-322
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2011

ICMJE     Data element required by the

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

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