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

Phase 2

Completed

• Conditions: Chronic Constipation
• Interventions: Drug: KWA-0711; Drug: Placebo

• Registration Number: NCT01938196
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2014-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KWA-0711 Dose1	KWA-0711	-
KWA-0711 Dose3	KWA-0711	-
Placebo	Placebo	-
KWA-0711 Dose2	KWA-0711	-
KWA-0711 Dose4	KWA-0711	-

Primary Outcome Measures

Name	Time	Method
Improvement of signs and symptoms associated with constipation	5 weeks	* Frequency of Spontaneous Bowel Movements; * Bowel Movement Timing; * Stool Consistency; * Abdominal Assessment; * QOL Assessment