A Long-Term Study To Evaluate Safety And Efficacy Of Pegabalin For Pain Associated With Diabetic Peripheral Neuropathy

Condition(s) targeted: Diabetic Neuropathy, Painful

Intervention: 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

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Official title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: Safety and tolerability of pregabalin

Secondary outcome: Short-Form McGill Pain Questionnaire

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

Criteria:

Inclusion Criteria:

- Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy

in Study A0081163.

- Patients must be able to understand and cooperate with study procedures and have

signed a written informed consent prior to entering the study

Exclusion Criteria:

- Patients who experienced serious adverse events in the preceding study (A0081163) that

were determined by the investigator or the study sponsor to be causally related to the study medication.

- Patients exhibiting treatment non-compliance in the preceding study (A0081163)

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

Pfizer Investigational Site, Fukuoka, Japan; Not yet recruiting

Pfizer Investigational Site, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Niigata, Japan; Not yet recruiting

Pfizer Investigational Site, Oita, Japan; Recruiting

Pfizer Investigational Site, Tokushima, Japan; Recruiting

Pfizer Investigational Site, Nagoya, Aichi, 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, Kobe, Hyogo, Japan; Not yet recruiting

Pfizer Investigational Site, Yokohama, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Kamakura, Kanagawa, 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, Uruma, Okinawa, Japan; Not yet 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; Not yet recruiting

Pfizer Investigational Site, Yao, Osaka, Japan; Not yet recruiting

Pfizer Investigational Site, Higashiosaka, Osaka, Japan; Not yet 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; Not yet recruiting

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

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

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

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

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

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

Pfizer Investigational Site, Nishitokyo, Tokyo, Japan; Not yet recruiting

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

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