Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

NCT00553475

Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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.
Painful Diabetic 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

- Visual Analogue Scale (VAS) of pain is higher than 40 mm.

- Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

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


- Malignancy within the past 2 years.


- Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment
of neuropathy pain

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]

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.

Based on your search, you may also be interested in

Painful Diabetic NeuropathyA Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553280
  1. Nagoya, Aichi
  2. Date-shi, Fukushima
  3. Nihonmatsu, Fukushima
  4. Shirakawa-shi, Fukushima
  5. Sukagawa, Fukushima
  6. Kamakura, Kanagawa
  7. Yokohama, Kanagawa
  8. Sendai, Miyagi
  9. Matsumoto, Nagano
  10. Ueda, Nagano
  11. Beppu, Oita
  12. Yamada, Okayama
  13. Naha, Okinawa
  14. Tomishiro, Okinawa
  15. Urazoe, Okinawa
  16. Hirano-ku, Osaka
  17. Suminoe-ku, Osaka
  18. Sunto-gun, Shizuoka
  19. Oyama-shi, Tochigi
  20. Arakawa, Tokyo
  21. Bunkyo-ku, Tokyo
  22. Chiyoda-ku, Tokyo
  23. Ohta-ku, Tokyo
  24. Shibuya-ku, Tokyo
  25. Fukuoka,
  26. Oita,
  27. Tokushima,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Painful Diabetic NeuropathyRandomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553475
  1. Nagoya, Aichi
  2. Chikushino, Fukuoka
  3. Kasuga, Fukuoka
  4. Date-shi, Fukushima
  5. Nihonmatsu, Fukushima
  6. Shirakawa-shi, Fukushima
  7. Sukagawa, Fukushima
  8. Kure, Hiroshima
  9. Chitose, Hokkaido
  10. Ebetu, Hokkaido
  11. Sapporo, Hokkaido
  12. Sapporo, Hokkaiido
  13. Kobe, Hyogo
  14. Inashiki, Ibaraki
  15. Kamakura, Kanagawa
  16. Yokohama, Kanagawa
  17. Yatsushiro, Kumamoto
  18. Sendai, Miyagi
  19. Matsumoto, Nagano
  20. Ueda, Nagano
  21. Beppu, Oita
  22. Yamada, Okayama
  23. Naha, Okinawa
  24. Tomishiro, Okinawa
  25. Urazoe, Okinawa
  26. Higashiosaka, Osaka
  27. Hirano-ku, Osaka
  28. Kishiwada, Osaka
  29. Suminoe-ku, Osaka
  30. Sunto-gun, Shizuoka
  31. Oyama-shi, Tochigi
  32. Utsunomiya, Tochigi
  33. Arakawa, Tokyo
  34. Bunkyo-ku, Tokyo
  35. Chiyoda-ku, Tokyo
  36. Chuo-ku, Tokyo
  37. Minato-ku, Tokyo
  38. Nishitokyo, Tokyo
  39. Ohta-ku, Tokyo
  40. Shibuya-ku, Tokyo
  41. Fukuoka,
  42. Kumamoto,
  43. Nagasaki,
  44. Niigata,
  45. Oita,
  46. Okayama,
  47. Saga,
  48. Saitama,
  49. Tokushima,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Painful Diabetic NeuropathyA Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
NCT00156078
  1. Buenos Aires,
  2. Belo Horizonte, MG
  3. Niteroi, RJ
  4. Providencia, Santiago
  5. Valparaiso, V Region
  6. Medellin, Antioquia
  7. Bogotá, Cundinamarca
  8. Quito, Pichincha
  9. Jakarta Pusat,
  10. Surabaya,
  11. Amman,
  12. Pusan,
  13. Seoul,
  14. Beirut,
  15. Kuala Lumpur,
  16. Monterrey, Nuevo Leon
  17. Mexico Df,
  18. San Luis Potosi,
  19. Espana, Manila
  20. Quezon City,
  21. Riyadh,
  22. Singapore,
  23. Gueishan Shiang, Taoyan Hsien
  24. Taipei,
  25. Khet Rajathevee, Bangkok
  26. Muang, Chiang Mai
  27. Capa, Istanbul
  28. Ankara,
  29. Istanbul,
  30. Izmir,
  31. Mersin,
  32. Abu Dhabi,
  33. El Hatillo, Caracas-Estado Miranda
  34. Caracas, Distrito Capital
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Official Title  ICMJE Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients 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 (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: placebo
    Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 600 mg/day
    Intervention: Drug: pregabalin
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
Actual Enrollment  ICMJE
 (submitted: June 17, 2009)
314
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2007)
308
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Visual Analogue Scale (VAS) of pain is higher than 40 mm.
  • Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

  • Malignancy within the past 2 years.
  • Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553475
Other Study ID Numbers  ICMJE A0081163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2010

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