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

Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02343978

Enrollment

Registered

2015-01-22

Start date

2014-12-26

Completion date

Unknown

Last updated

2017-05-22

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, CC

Brief summary

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

Interventions

DRUGKWA-0711

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Inclusion criteria

* The patients who experienced fewer than three Spontaneous Bowel Movements (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
Incidence of Adverse Events	2 weeks

Secondary

Measure	Time frame
Change in fasting and postprandial blood glucose levels	2 weeks
Change in fasting and postprandial insulin levels	2 weeks
ECGs, vital signs, and clinical labs	2 weeks
Improvement of signs and symptoms associated with constipation	2 weeks

Countries

Japan

Outcome results

None listed

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