Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
NCT ID: NCT02281630
Last Updated: 2017-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
388 participants
INTERVENTIONAL
2014-10-15
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
QUADRUPLE
Study Groups
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KWA-0711 High dose
KWA-0711
KWA-0711 Low dose
KWA-0711
Placebo
Placebo
Interventions
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KWA-0711
Placebo
Eligibility Criteria
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Inclusion Criteria
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.
Exclusion Criteria
* Patients who have organic constipation.
* Patients who received intestinal resection.
20 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tatsuro Takei
Role: STUDY_DIRECTOR
Kissei Pharmaceutical Co., Ltd.
Locations
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Tokyo and Other Japanese City, , Japan
Countries
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References
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Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.
Other Identifiers
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KWA1204
Identifier Type: -
Identifier Source: org_study_id
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