A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation

Phase 2CompletedNCT01937663

Kissei Pharmaceutical Co., Ltd.

Overview

The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.

Study Type

INTERVENTIONAL

Conditions

Chronic Constipation

Interventions

KWA-0711DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patients who experienced fewer than three spontaneous bowel movements 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.

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Improvement of signs and symptoms associated with constipation

* Frequency of Spontaneous Bowel Movements * Bowel Movement Timing * Stool Consistency * Abdominal Assessment * QOL Assessment

Time frame: 4 weeks

Data from ClinicalTrials.gov

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