Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

NCT01455415

Last updated date
Study Location
Dedicated Clinical Research
Goodyear, Arizona, 85395, 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.
Painful Diabetic Peripheral 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

- Type 1 or 2 diabetes with painful neuropathy

- Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose

- Meet pre-defined level of pain severity at entrance

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


- History of failed pregabalin treatment due to lack of efficacy at therapeutic dose


- Participated in a previous or ongoing pregabalin clinical trial


- Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment
of distal neuropathic pain

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Painful Diabetic Peripheral NeuropathyEffect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
NCT01455415
  1. Goodyear, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Tucson, Arizona
  8. Fresno, California
  9. Lakewood, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Walnut Creek, California
  15. New London, Connecticut
  16. New London, Connecticut
  17. Waterbury, Connecticut
  18. Bradenton, Florida
  19. Brooksville, Florida
  20. Fort Myers, Florida
  21. Hallandale Beach, Florida
  22. Hialeah, Florida
  23. Palm Beach Gardens, Florida
  24. St. Petersburg, Florida
  25. Tampa, Florida
  26. Winter Haven, Florida
  27. Columbus, Georgia
  28. Chicago, Illinois
  29. Naperville, Illinois
  30. Lexington, Kentucky
  31. Monroe, Louisiana
  32. Brockton, Massachusetts
  33. Brockton, Massachusetts
  34. Fall River, Massachusetts
  35. Kalamazoo, Michigan
  36. Kalamazoo, Michigan
  37. St. Louis, Missouri
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Las Vegas, Nevada
  42. New York, New York
  43. Lexington, North Carolina
  44. Cincinnati, Ohio
  45. Columbus, Ohio
  46. Oklahoma City, Oklahoma
  47. Oklahoma City, Oklahoma
  48. Medford, Oregon
  49. Altoona, Pennsylvania
  50. Duncansville, Pennsylvania
  51. Orangeburg, South Carolina
  52. Knoxville, Tennessee
  53. Dallas, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. Pelhrimov,
  57. Praha 10,
  58. Praha 5,
  59. Roma,
  60. Malmo,
  61. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
Official Title  ICMJE A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Brief Summary This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • Drug: pregabalin
    150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
  • Drug: placebo
    matching placebo 3 time a day
Study Arms  ICMJE
  • Experimental: 1: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2: Placebo
    Intervention: Drug: placebo
Publications * Raskin P, Huffman C, Yurkewicz L, Pauer L, Scavone JM, Yang R, Parsons B. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016 Mar;32(3):203-10. doi: 10.1097/AJP.0000000000000254.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
306
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2011)
300
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 or 2 diabetes with painful neuropathy
  • Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
  • Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

  • History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
  • Participated in a previous or ongoing pregabalin clinical trial
  • Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
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 Czech Republic,   Italy,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01455415
Other Study ID Numbers  ICMJE A0081268
2011-002743-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP