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

A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01600001

Enrollment

Registered

2012-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Constipation

Keywords

Chronic Idiopathic Constipation (CIC), Constipation, Functional gastrointestinal disorders

Brief summary

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

Interventions

DRUGKWA-0711

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Improvement of signs and symptoms associated with constipation	4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026