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

Kissei

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Drug: KWA-0711

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343978

KWA1205

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

KWA-0711 High dose

Experimental group

Treatment:

Drug: KWA-0711

KWA-0711 Low dose

Experimental group

Treatment:

Drug: KWA-0711