Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT00553475
Last Updated: 2021-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
314 participants
INTERVENTIONAL
2007-10-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
placebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Pregabalin 300 mg/day
pregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Pregabalin 600 mg/day
pregabalin
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Interventions
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placebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
pregabalin
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year
Exclusion Criteria
* Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Chikushino-shi, Fukuoka, Japan
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Pfizer Investigational Site
Date-shi, Fukushima, Japan
Pfizer Investigational Site
Nihommatsu, Fukushima, Japan
Pfizer Investigational Site
Shirakawa-shi, Fukushima, Japan
Pfizer Investigational Site
Sukagawa, Fukushima, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Chitose, Hokkaido, Japan
Pfizer Investigational Site
Ebetu, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaiido, Japan
Pfizer Investigational Site
Kobe, Hyōgo, Japan
Pfizer Investigational Site
Inashiki, Ibaraki, Japan
Pfizer Investigational Site
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Yatsushiro, Kumamoto, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Matsumoto, Nagano, Japan
Pfizer Investigational Site
Ueda, Nagano, Japan
Pfizer Investigational Site
Beppu, Oita Prefecture, Japan
Pfizer Investigational Site
Yamada, Okayama-ken, Japan
Pfizer Investigational Site
Naha, Okinawa, Japan
Pfizer Investigational Site
Tomishiro, Okinawa, Japan
Pfizer Investigational Site
Urazoe, Okinawa, Japan
Pfizer Investigational Site
Higashiosaka, Osaka, Japan
Pfizer Investigational Site
Hirano-ku, Osaka, Japan
Pfizer Investigational Site
Kishiwada, Osaka, Japan
Pfizer Investigational Site
Suminoe-ku, Osaka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Oyama-shi, Tochigi, Japan
Pfizer Investigational Site
Utsunomiya, Tochigi, Japan
Pfizer Investigational Site
Arakawa City, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Nishitōkyō, Tokyo, Japan
Pfizer Investigational Site
Ohta-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, , Japan
Pfizer Investigational Site
Kumamoto, , Japan
Pfizer Investigational Site
Nagasaki, , Japan
Pfizer Investigational Site
Niigata, , Japan
Pfizer Investigational Site
Okayama, , Japan
Pfizer Investigational Site
Ōita, , Japan
Pfizer Investigational Site
Saga, , Japan
Pfizer Investigational Site
Saitama, , Japan
Pfizer Investigational Site
Tokushima, , Japan
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081163
Identifier Type: -
Identifier Source: org_study_id
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