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

Last updated: January 21, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00553475
A0081163
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Malignancy within the past 2 years.
  • Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessmentof neuropathy pain

Study Design

Total Participants: 314
Study Start date:
October 01, 2007
Estimated Completion Date:
March 31, 2009

Connect with a study center

  • Pfizer Investigational Site

    Nagoya, Aichi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chikushino, Fukuoka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kasuga, Fukuoka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Date-shi, Fukushima
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nihonmatsu, Fukushima
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Shirakawa-shi, Fukushima
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Sukagawa, Fukushima
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kure, Hiroshima
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chitose, Hokkaido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Ebetu, Hokkaido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Sapporo, Hokkaiido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kobe, Hyogo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Inashiki, Ibaraki
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kamakura, Kanagawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Yokohama, Kanagawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Yatsushiro, Kumamoto
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Sendai, Miyagi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Matsumoto, Nagano
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Ueda, Nagano
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Beppu, Oita
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Yamada, Okayama
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Naha, Okinawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Tomishiro, Okinawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Urazoe, Okinawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Higashiosaka, Osaka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Hirano-ku, Osaka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kishiwada, Osaka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Suminoe-ku, Osaka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Sunto-gun, Shizuoka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Oyama-shi, Tochigi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Utsunomiya, Tochigi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Arakawa, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chiyoda-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chuo-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Minato-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nishitokyo, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Ohta-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Shibuya-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Fukuoka,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kumamoto,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nagasaki,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Niigata,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Oita,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Okayama,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Saga,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Saitama,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Tokushima,
    Japan

    Site Not Available

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