A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT00553280
Last Updated: 2021-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2008-02-29
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pregabalin
pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Interventions
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pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 exhibiting treatment non-compliance in the preceding study (A0081163)
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
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
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, 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
Hirano-ku, 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
Arakawa City, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Ohta-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, , Japan
Pfizer Investigational Site
Ōita, , Japan
Pfizer Investigational Site
Tokushima, , Japan
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081164
Identifier Type: -
Identifier Source: org_study_id
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