Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

NCT ID: NCT02281630

Last Updated: 2017-05-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-15

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.

Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KWA-0711 High dose

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

KWA-0711 Low dose

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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KWA-0711

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.
* 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 secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Japan

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.

Reference Type DERIVED
PMID: 30056028 (View on PubMed)

Other Identifiers

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KWA1204

Identifier Type: -

Identifier Source: org_study_id

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