Clinical trial NCT00553280: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Official title: An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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)

Primary outcomes:
measure: Summary of Adverse Events
timeFrame: 53 weeks
Secondary outcomes:
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
timeFrame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
timeFrame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
timeFrame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
timeFrame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
timeFrame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Date-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Nihonmatsu
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Shirakawa-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Sukagawa
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Kamakura
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Matsumoto
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Ueda
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Beppu
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Yamada
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Naha
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Tomishiro
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Urazoe
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Hirano-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suminoe-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Oyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Arakawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Ohta-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Tokushima
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011 Nov 30;2(6):457-63. doi: 10.1111/j.2040-1124.2011.00122.x.