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

NCT00283842

Last updated date
Study Location
Mesa, Arizona, 85210, United States
Contact
1-800-718-1021

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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

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Diabetic Neuropathies, PainStudy Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy NCT00283842
  1. Mesa, Arizona
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Encino, California
  5. Newport Beach, California
  6. Walnut Creek, California
  7. Pueblo, Colorado
  8. New Britain, Connecticut
  9. Stratford, Connecticut
  10. Waterbury, Connecticut
  11. Ft. Myers, Florida
  12. Palm Beach Gardens, Florida
  13. Pembroke Pines, Florida
  14. St. Petersburg, Florida
  15. West Palm Beach, Florida
  16. Lawrenceville, Georgia
  17. Roswell, Georgia
  18. Coeur D'Alene, Idaho
  19. Chicago, Illinois
  20. Evansville, Indiana
  21. Des Moines, Iowa
  22. Madisonville, Kentucky
  23. Springfield, Massachusetts
  24. Ann Arbor, Michigan
  25. Kansas City, Missouri
  26. St. Louis, Missouri
  27. St. Louis, Missouri
  28. Billings, Montana
  29. Omaha, Nebraska
  30. Albany, New York
  31. Flushing, New York
  32. New York, New York
  33. Rochester, New York
  34. Staten Island, New York
  35. Fargo, North Dakota
  36. Cincinnati, Ohio
  37. Dayton, Ohio
  38. Toledo, Ohio
  39. Collegeville, Pennsylvania
  40. Feasterville, Pennsylvania
  41. Harleysville, Pennsylvania
  42. Warwick, Rhode Island
  43. Austin, Texas
  44. Dallas, Texas
  45. San Antonio, Texas
  46. Midvale, Utah
  47. Salt Lake City, Utah
  48. Virginia Beach, Virginia
  49. Lakewood, Washington
  50. Tacoma, Washington
  51. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 MonitorWyeth 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