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

Phase 2

Completed

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

• Registration Number: NCT02343978
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-26
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Primary Completion: 2015-05-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• The patients who experienced fewer than three Spontaneous Bowel Movements (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KWA-0711 High dose	KWA-0711	-
KWA-0711 Low dose	KWA-0711	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	2 weeks

Secondary Outcome Measures

Name	Time	Method
Change in fasting and postprandial blood glucose levels	2 weeks
Change in fasting and postprandial insulin levels	2 weeks
ECGs, vital signs, and clinical labs	2 weeks
Improvement of signs and symptoms associated with constipation	2 weeks