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

Kissei

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Drug: Placebo; Drug: KWA-0711

Study type: Interventional

Funder types: Industry

Identifiers

NCT02281630

KWA1204

Details and patient eligibility

About

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.

Enrollment: 388 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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388 participants in 3 patient groups, including a placebo group

KWA-0711 High dose

Experimental group

Treatment:

Drug: KWA-0711

KWA-0711 Low dose

Experimental group

Treatment:

Drug: KWA-0711

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo