Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
NCT ID: NCT00830167
Last Updated: 2021-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
498 participants
INTERVENTIONAL
2009-03-31
2011-05-31
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
TRIPLE
Study Groups
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Placebo
Placebo
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Pregabalin
Pregabalin
Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Interventions
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Placebo
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Pregabalin
Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Eligibility Criteria
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Inclusion Criteria
* A score of more or equal to 40 mm on the Pain VAS
* An average score more or equal to 4 on 4 daily pain diaries
Exclusion Criteria
* Patients with severe depression
* Patients taking excluded medications
* Patients with suicidality
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
Ichihara-shi, Chiba, Japan
Pfizer Investigational Site
Yotukaidou, Chiba, Japan
Pfizer Investigational Site
Matuyama-si, Ehime, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Iiduka, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kobe, Hyōgo, Japan
Pfizer Investigational Site
Mito, Ibaraki, Japan
Pfizer Investigational Site
Morioka, Iwate, Japan
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Pfizer Investigational Site
Tsu, Mie-ken, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Hiki-gun, Saitama, Japan
Pfizer Investigational Site
Saitama, Saitama, Japan
Pfizer Investigational Site
Saitama-shi, Saitama, Japan
Pfizer Investigational Site
Aoi-ku, Shizuoka, Japan
Pfizer Investigational Site
Shimotsuga-gun, Tochigi, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Chuou-Ku, Tokyo, Japan
Pfizer Investigational Site
Itabashi-Ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya City, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site
Toyama, Toyama, Japan
Pfizer Investigational Site
Nagano, , Japan
Pfizer Investigational Site
Osaka, , Japan
Pfizer Investigational Site
Ōita, , Japan
Pfizer Investigational Site
Tokushima, , Japan
Pfizer Investigational Site
Yokohama, , Japan
Countries
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References
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Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
Ohta H, Oka H, Usui C, Ohkura M, Suzuki M, Nishioka K. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Res Ther. 2012 Oct 12;14(5):R217. doi: 10.1186/ar4056.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081208
Identifier Type: -
Identifier Source: org_study_id
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