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

Condition(s) targeted: Diabetic Neuropathy, Painful

Intervention: placebo (Drug); pregabalin (Drug); pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: Numerical rating scale for pain

Secondary outcome:

Clinical Global Impression of Change

Short Form 36-item (SF-36) Health Survey

Daily Sleep Interference Diary

Short-form McGill Pain Questionnaire

Medical Outcomes Study (MOS) - Sleep Scale for sleep

Patient Global Impression of Change

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Kumamoto, Japan; Recruiting

Pfizer Investigational Site, Nagasaki, Japan; Recruiting

Pfizer Investigational Site, Niigata, Japan; Recruiting

Pfizer Investigational Site, Oita, Japan; Recruiting

Pfizer Investigational Site, Okayama, Japan; Recruiting

Pfizer Investigational Site, Saga, Japan; Recruiting

Pfizer Investigational Site, Saitama, Japan; Recruiting

Pfizer Investigational Site, Tokushima, Japan; Recruiting

Pfizer Investigational Site, Nagoya, Aichi, Japan; Recruiting

Pfizer Investigational Site, Kasuga, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Chikushino, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Kohriyama, Fukushima, Japan; Recruiting

Pfizer Investigational Site, Sukagawa, Fukushima, Japan; Recruiting

Pfizer Investigational Site, Nihonmatsu, Fukushima, Japan; Recruiting

Pfizer Investigational Site, Shirakawa-shi, Fukushima, Japan; Recruiting

Pfizer Investigational Site, Date-shi, Fukushima, Japan; Recruiting

Pfizer Investigational Site, Kure, Hiroshima, Japan; Recruiting

Pfizer Investigational Site, Ebetu, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Chitose, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Sapporo, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Sapporo, Hokkaiido, Japan; Recruiting

Pfizer Investigational Site, Kobe, Hyogo, Japan; Recruiting

Pfizer Investigational Site, Inashiki, Ibaraki, Japan; Recruiting

Pfizer Investigational Site, Yokohama, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Kamakura, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Yatsushiro, Kumamoto, Japan; Recruiting

Pfizer Investigational Site, Sendai, Miyagi, Japan; Recruiting

Pfizer Investigational Site, Ueda, Nagano, Japan; Recruiting

Pfizer Investigational Site, Matsumoto, Nagano, Japan; Recruiting

Pfizer Investigational Site, Beppu, OITA, Japan; Recruiting

Pfizer Investigational Site, Yamada, Okayama, Japan; Recruiting

Pfizer Investigational Site, Naha, Okinawa, Japan; Recruiting

Pfizer Investigational Site, Urazoe, Okinawa, Japan; Recruiting

Pfizer Investigational Site, Tomishiro, Okinawa, Japan; Recruiting

Pfizer Investigational Site, Suminoe-ku, Osaka, Japan; Recruiting

Pfizer Investigational Site, Kishiwada, Osaka, Japan; Recruiting

Pfizer Investigational Site, Yao, Osaka, Japan; Recruiting

Pfizer Investigational Site, Higashiosaka, Osaka, Japan; Recruiting

Pfizer Investigational Site, Hirano-ku, Osaka, Japan; Recruiting

Pfizer Investigational Site, Sunto-gun, Shizuoka, Japan; Recruiting

Pfizer Investigational Site, Utsunomiya, Tochigi, Japan; Recruiting

Pfizer Investigational Site, Oyama-shi, Tochigi, Japan; Recruiting

Pfizer Investigational Site, Arakawa, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Ohta-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Shibuya-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Shinjuku-ku, Tokyo, Japan; Not yet recruiting

Pfizer Investigational Site, Bunkyo-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Minato-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Chiyoda-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Chuo-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Nishitokyo, Tokyo, Japan; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2007
Ending date: September 2010
Last updated: October 30, 2008