Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

Back to Search
Print
Bookmark Trial

NCT01474772

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
See other locations
Contact
1-800-718-1021
[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 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

- Men or women who are at least 18 years old.

- Diagnosis of painful diabetic peripheral neuropathy.

- Pain on walking.

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


- Inability to walk 50 feet on a flat surface.


- Pain on walking due to conditions other than diabetic peripheral neuropathy.

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 Peripheral NeuropathyA Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
NCT01087203
  1. Mobile, Alabama
  2. Goodyear, Arizona
  3. Litchfield Park, Arizona
  4. Little Rock, Arkansas
  5. Fullerton, California
  6. Irvine, California
  7. La Jolla, California
  8. Boulder, Colorado
  9. Atlantis, Florida
  10. Bradenton, Florida
  11. Clearwater, Florida
  12. Destin, Florida
  13. Fort Walton Beach, Florida
  14. Hallandale Beach, Florida
  15. Palm Beach Gardens, Florida
  16. Sunrise, Florida
  17. West Palm Beach, Florida
  18. Decatur, Georgia
  19. Fort Wayne, Indiana
  20. Greenfield, Indiana
  21. Greenfirld, Indiana
  22. Lenexa, Kansas
  23. Hollywood, Maryland
  24. Ann Arbor, Michigan
  25. Nixa, Missouri
  26. Springfield, Missouri
  27. Missoula, Montana
  28. Asheville, North Carolina
  29. Dayton, Ohio
  30. Dayton, Ohio
  31. Toledo, Ohio
  32. Oklahoma City, Oklahoma
  33. Oklahoma, Oklahoma
  34. Greensburg, Pennsylvania
  35. Orangeburg, South Carolina
  36. Houston, Texas
  37. San Antonio, Texas
  38. San Antonio, Texas
  39. Salt Lake City, Utah
  40. Salt Lake City, Utah
  41. West Jordan, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetic Peripheral NeuropathyEfficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
NCT01474772
  1. Goodyear, Arizona
  2. Phoenix, Arizona
  3. Fresno, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Brandon, Florida
  8. Brandon, Florida
  9. Clearwater, Florida
  10. North Palm Beach, Florida
  11. Tampa, Florida
  12. West Palm Beach, Florida
  13. Winter Haven, Florida
  14. Columbus, Georgia
  15. Evansville, Indiana
  16. Wichita, Kansas
  17. Omaha, Nebraska
  18. Henderson, Nevada
  19. Las Vegas, Nevada
  20. Las Vegas, Nevada
  21. New York, New York
  22. Toledo, Ohio
  23. Oklahoma City, Oklahoma
  24. Oklahoma City, Oklahoma
  25. Medford, Oregon
  26. Portland, Oregon
  27. Portland, Oregon
  28. Altoona, Pennsylvania
  29. Duncansville, Pennsylvania
  30. Pawtucket, Rhode Island
  31. Orangeburg, South Carolina
  32. Houston, Texas
  33. Houston, Texas
  34. Norfolk, Virginia
  35. Brno-Bystrc,
  36. Praha 10,
  37. Praha 5,
  38. Johannesburg, Gauteng
  39. Lenasia, Gauteng
  40. Durban, Kwa-Zulu Natal
  41. Richards Bay,
  42. Falkoping,
  43. Malmo,
  44. Stockholm,
  45. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetic Peripheral NeuropathySafety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
NCT00159731
  1. Hot Springs, Arkansas
  2. La Jolla, California
  3. Torrance, California
  4. Torrance, California
  5. Denver, Colorado
  6. Ocala, Florida
  7. Ocala, Florida
  8. Palm Beach Gardens, Florida
  9. Sunrise, Florida
  10. West Palm Beach, Florida
  11. West Palm Beach, Florida
  12. Boston, Massachusetts
  13. Omaha, Nebraska
  14. Omaha, Nebraska
  15. Las Vegas, Nevada
  16. Englewood, New Jersey
  17. New Brunswick, New Jersey
  18. Albany, New York
  19. Rochester, New York
  20. Rochester, New York
  21. Greenville, North Carolina
  22. Toledo, Ohio
  23. Duncansville, Pennsylvania
  24. Dallas, Texas
  25. Dallas, Texas
  26. Houston, Texas
  27. San Antonio, Texas
  28. Salt Lake City, Utah
  29. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Official Title  ICMJE A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
Brief Summary The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.
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 Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • Drug: Pregabalin
    150-300 mg/day given in 3 divided doses as capsules
    Other Name: Lyrica
  • Other: placebo
    matching placebo capsules given in 3 divided doses
Study Arms  ICMJE
  • Experimental: Pregabain
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Publications * Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.

*   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: November 17, 2014)		217
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2011)		175
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women who are at least 18 years old.
  • Diagnosis of painful diabetic peripheral neuropathy.
  • Pain on walking.

Exclusion Criteria:

  • Inability to walk 50 feet on a flat surface.
  • Pain on walking due to conditions other than diabetic peripheral neuropathy.
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,   South Africa,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474772
Other Study ID Numbers  ICMJE A0081269
2011-003266-32 ( 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 November 2014

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