Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Back to Search
Print
Bookmark Trial

NCT00143156

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406, United States
See other locations
Contact
1-800-718-1021
Cl[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Neuropathies
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

- Males or females at least 18 years of age, of any ethnic origin

- Type 1 or 2 diabetes mellitus

- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

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


- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the
assessment of neuropathic pain.


- Presence of severe pain associated with conditions other than diabetic peripheral
neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Diabetic NeuropathiesA Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
NCT00644748
  1. Fortaleza, Ceara
  2. Taguatinga, DF
  3. Belo Horizonte, MG
  4. Curitiba, Parana
  5. Recife, Pernambuco
  6. Rio de Janeiro, RJ
  7. Porto Alegre, RS
  8. Sao Paulo, SP
  9. Sao Paulo, SP
ALL GENDERS
51 Years+
years
MULTIPLE SITES
Diabetic NeuropathiesPregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT00143156
  1. Tuscaloosa, Alabama
  2. Phoenix, Arizona
  3. Little Rock, Arkansas
  4. La Mesa, California
  5. Los Gatos, California
  6. Northridge, California
  7. Tustin, California
  8. Walnut Creek, California
  9. Boulder, Colorado
  10. Wheatridge, Colorado
  11. New Haven, Connecticut
  12. Clearwater, Florida
  13. Hollywood, Florida
  14. Ocala, Florida
  15. Tampa, Florida
  16. West Palm Beach, Florida
  17. Atlanta, Georgia
  18. Atlanta, Georgia
  19. Atlanta, Georgia
  20. Decatur, Georgia
  21. Chicago, Illinois
  22. Chicago, Illinois
  23. Peoria, Illinois
  24. Springfield, Illinois
  25. Indianapolis, Indiana
  26. Lexington, Kentucky
  27. Baltimore, Maryland
  28. Boston, Massachusetts
  29. Boston, Massachusetts
  30. Springfield, Massachusetts
  31. Jackson, Mississippi
  32. Tupelo, Mississippi
  33. Jefferson City, Missouri
  34. St Louis, Missouri
  35. St. Louis, Missouri
  36. Omaha, Nebraska
  37. Englewood, New Jersey
  38. Shrewsbury, New Jersey
  39. New Hyde Park, New York
  40. New York, New York
  41. New York, New York
  42. Kettering, Ohio
  43. Toledo, Ohio
  44. Tulsa, Oklahoma
  45. Warwick, Rhode Island
  46. Memphis, Tennessee
  47. Dallas, Texas
  48. Frisco, Texas
  49. Houston, Texas
  50. San Antonio, Texas
  51. San Antonio, Texas
  52. Salt Lake City, Utah
  53. Burlington, Vermont
  54. Charlottesvlle, Virginia
  55. Ponce,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetic NeuropathiesA Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
NCT00625833
  1. Anniston, Alabama
  2. Birmingham, Alabama
  3. Mission Viejo, California
  4. Denver, Colorado
  5. New Britain, Connecticut
  6. Waterbury, Connecticut
  7. Tampa, Florida
  8. Winter Haven, Florida
  9. Lexington, Kentucky
  10. Louisville, Kentucky
  11. North Dartmouth, Massachusetts
  12. Jackson, Mississippi
  13. Tupelo, Mississippi
  14. Marionville, Missouri
  15. Springfield, Missouri
  16. Elizabeth, New Jersey
  17. Hamilton, New Jersey
  18. Buffalo, New York
  19. New York, New York
  20. New York, New York
  21. Cranston, Rhode Island
  22. Cumberland, Rhode Island
  23. Myrtle Beach, South Carolina
  24. Bartlett, Tennessee
  25. Beaumont, Texas
  26. Beaumont, Texas
  27. Dallas, Texas
  28. Dallas, Texas
  29. Dallas, Texas
  30. Houston, Texas
  31. Houston, Texas
  32. Milwaukee, Wisconsin
  33. Brno,
  34. Ceske Budejovice,
  35. Ostrava,
  36. Zlin,
  37. Helsinki,
  38. Kokkola,
  39. Lahti,
  40. Lohja,
  41. Almere,
  42. Amsterdam,
  43. Venlo,
  44. Worcester, Cape Town
  45. Bloemfontein, Free State
  46. Ennerdale, Gauteng
  47. Tshwane, Gauteng
  48. Stanger, Kwa- Zulu Natal
  49. Durban, KwaZulu Natal
  50. Cape Town,
  51. L'hospitalet de Llobregat, Barcelona
  52. Santiago de Compostela, LA Coruña
  53. Barcelona,
  54. Madrid,
  55. Pontevedra,
  56. Valencia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful 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: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathies
Intervention  ICMJE Drug: pregabalin
Study Arms  ICMJE Not Provided
Publications *

*   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
Enrollment  ICMJE
 (submitted: August 31, 2005)		450
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females at least 18 years of age, of any ethnic origin
  • Type 1 or 2 diabetes mellitus
  • Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

  • Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
  • Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
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 Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143156
Other Study ID Numbers  ICMJE A0081071
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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