Clinical trial NCT00553475: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Number of Responders
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline at Week 1 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 1
measure: Change From Baseline at Week 2 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 2
measure: Change From Baseline at Week 3 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 3
measure: Change From Baseline at Week 4 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 4
measure: Change From Baseline at Week 5 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 5
measure: Change From Baseline at Week 6 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 6
measure: Change From Baseline at Week 7 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 7
measure: Change From Baseline at Week 8 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 8
measure: Change From Baseline at Week 9 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 9
measure: Change From Baseline at Week 10 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 10
measure: Change From Baseline at Week 11 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 11
measure: Change From Baseline at Week 12 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 12
measure: Change From Baseline at Week 13 in Mean Weekly Pain Scores
timeFrame: From baseline to Week 13
Secondary outcomes:
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Mean Sleep Interference Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
timeFrame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
measure: Clinical Global Impression of Change
timeFrame: Week 13 or up to discontinuation
measure: Patient Global Impression of Change
timeFrame: Week 13 or up to discontinuation
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Chikushino
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kasuga
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
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: Kure
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Chitose
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Ebetu
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaiido
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Inashiki
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Kamakura
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yatsushiro
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
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: Higashiosaka
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Hirano-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kishiwada
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: Utsunomiya
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: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nishitokyo
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: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Nagasaki
country: Japan
facility: Pfizer Investigational Site
city: Niigata
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Okayama
country: Japan
facility: Pfizer Investigational Site
city: Saga
country: Japan
facility: Pfizer Investigational Site
city: Saitama
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: Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
citation: Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
citation: Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
citation: Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
citation: Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.