Study Results
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View full resultsBasic Information
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COMPLETED
NA
765 participants
INTERVENTIONAL
2015-01-31
2017-05-25
Brief Summary
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Detailed Description
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\[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo (14-weeks)
Placebo
Placebo
DS-5565 15 mg Group
DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
DS-5565
DS-5565 20 mg Group
DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
DS-5565
DS-5565 30 mg Group
DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
DS-5565
Interventions
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Placebo
Placebo
DS-5565
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At screening, a pain scale of ≥ 40 mm
Exclusion Criteria
20 Years
ALL
No
Sponsors
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SRL Medisearch Inc.
INDUSTRY
Quintiles, Inc.
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daichii Sankyo
Locations
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Medical Corporation Fujigaki Clinic
Ōita, , Japan
Countries
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References
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Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.
Kato J, Matsui N, Kakehi Y, Murayama E, Ohwada S. Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21976. doi: 10.1097/MD.0000000000021976.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DS5565-A-J304
Identifier Type: -
Identifier Source: org_study_id