Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT01504412
Last Updated: 2020-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
450 participants
INTERVENTIONAL
2012-01-31
2013-06-30
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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DS-5565 Low Dose
DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565
Oral tablets administered twice daily
DS-5565 Middle Dose
DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565
Oral tablets administered twice daily
DS-5565 High Dose
DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.
DS-5565
Oral tablets administered twice daily
Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.
Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
Pregabalin
Pregabalin capsules 300mg/day administered in 2 doses
Pregabalin capsules
Pregabalin oral capsules 150 mg administered twice a day
Interventions
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DS-5565
Oral tablets administered twice daily
DS-5565
Oral tablets administered twice daily
DS-5565
Oral tablets administered twice daily
Placebo
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
Pregabalin capsules
Pregabalin oral capsules 150 mg administered twice a day
Eligibility Criteria
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Inclusion Criteria
* Painful distal symmetric polyneuropathy
* Average daily pain score is great than or equal to 4
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tokyo, , Japan
Seoul, , South Korea
Taipei, , Taiwan
Countries
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References
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Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12.
Other Identifiers
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DS5565-A-J202
Identifier Type: -
Identifier Source: org_study_id
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