A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation

Kissei

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Drug: Placebo; Drug: KWA-0711

Study type: Interventional

Funder types: Industry

Identifiers

NCT01938196

KWA1202

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients who experienced fewer than three spontaneous bowel movements 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

0 participants in 5 patient groups, including a placebo group

KWA-0711 Dose1

Experimental group

Treatment:

Drug: KWA-0711

KWA-0711 Dose2

Experimental group

Treatment:

Drug: KWA-0711

KWA-0711 Dose3

Experimental group

Treatment:

Drug: KWA-0711

KWA-0711 Dose4

Experimental group

Treatment:

Drug: KWA-0711

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo