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

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.

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Detailed Description

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Conditions

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Chronic Idiopathic Constipation

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