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A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

NCT ID: NCT01600001

Last Updated: 2013-10-30

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

75 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.

Detailed Description

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Conditions

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Chronic Idiopathic Constipation

Keywords

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Chronic Idiopathic Constipation (CIC) Constipation Functional gastrointestinal disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Drug:KWA-0711 dose 1

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

Drug:KWA-0711 dose 2

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

Drug:KWA-0711 dose 3

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

Drug:KWA-0711 dose 4

Group Type EXPERIMENTAL

KWA-0711

Intervention Type DRUG

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

Locations

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Japan

Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KWA1201

Identifier Type: -

Identifier Source: org_study_id