A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Kissei

Status and phase: Completed; Phase 2

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: KWA-0711; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600001

KWA1201

Details and patient eligibility

About

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

Enrollment: 75 estimated 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: Double Blind

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75 participants in 5 patient groups, including a placebo group

Drug:KWA-0711 dose 1

Experimental group

Treatment:

Drug: KWA-0711

Drug:KWA-0711 dose 2

Experimental group

Treatment:

Drug: KWA-0711

Drug:KWA-0711 dose 3

Experimental group

Treatment:

Drug: KWA-0711

Drug:KWA-0711 dose 4

Experimental group

Treatment:

Drug: KWA-0711

Drug: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo