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

Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)

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

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: Placebo; Drug: KWA-0711

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo and Other Japanese City, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: KWA-0711 High dose	Drug: KWA-0711
Experimental: KWA-0711 Low dose	Drug: KWA-0711

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete SBM (CSBM) frequency and responder rate	4 weeks
SBM frequency and responder rate	4 weeks
Time to first SBM after the initial dose	4 weeks
Stool consistency	4 weeks
Degree of straining	4 weeks
Abdominal bloating and discomfort	4 weeks
Use of rescue medications	4 weeks
Global assessment of constipation severity	4 weeks
Japanese version of IBS-QOL	4 weeks
Global assessment of treatment effectiveness	4 weeks
Satisfaction rating for the condition of bowel movements	4 weeks
Adverse events, ECGs, vital signs, and clinical labs	4 weeks

Collaborators and Investigators

• Sponsor: Kissei Pharmaceutical Co., Ltd.
• Investigators: Study Director: Tatsuro Takei, Kissei Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25. Erratum In: Lancet Gastroenterol Hepatol. 2018 Sep;3(9):e4.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2014
• Primary Completion (Actual): April 28, 2015

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Constipation; CC
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: KWA1204