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

Chronic Constipation Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281630
• Other study ID #: KWA1204
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2014
• Last updated: May 18, 2017
• Start date: October 15, 2014

Study information

• Verified date: May 2017
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. primary completion date: April 28, 2015
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• KWA-0711

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1		1 week
Secondary	Complete SBM (CSBM) frequency and responder rate		4 weeks
Secondary	SBM frequency and responder rate		4 weeks
Secondary	Time to first SBM after the initial dose		4 weeks
Secondary	Stool consistency		4 weeks
Secondary	Degree of straining		4 weeks
Secondary	Abdominal bloating and discomfort		4 weeks
Secondary	Use of rescue medications		4 weeks
Secondary	Global assessment of constipation severity		4 weeks
Secondary	Japanese version of IBS-QOL		4 weeks
Secondary	Global assessment of treatment effectiveness		4 weeks
Secondary	Satisfaction rating for the condition of bowel movements		4 weeks
Secondary	Adverse events, ECGs, vital signs, and clinical labs		4 weeks