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

Chronic Constipation Clinical Trial

Official title:

Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343978
• Other study ID #: KWA1205
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2015
• Last updated: May 18, 2017
• Start date: December 26, 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 safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: May 1, 2015
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• KWA-0711

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	Incidence of Adverse Events		2 weeks
Secondary	Change in fasting and postprandial blood glucose levels		2 weeks
Secondary	Change in fasting and postprandial insulin levels		2 weeks
Secondary	ECGs, vital signs, and clinical labs		2 weeks
Secondary	Improvement of signs and symptoms associated with constipation		2 weeks