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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01938196
Enrollment
Unknown
Registered
2013-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2014-11-13

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

Conditions

Chronic Constipation

Keywords

Chronic Constipation, Constipation, Functional gastrointestinal disorders

Brief summary

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

Interventions

DRUGKWA-0711
DRUGPlacebo

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of signs and symptoms associated with constipation5 weeks* Frequency of Spontaneous Bowel Movements * Bowel Movement Timing * Stool Consistency * Abdominal Assessment * QOL Assessment

Countries

Japan

Outcome results

None listed

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