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

Chronic Constipation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938196
• Other study ID #: KWA1202
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2013
• Last updated: November 11, 2014

Study information

• Verified date: November 2014
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2014
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• KWA-0711

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of signs and symptoms associated with constipation	Frequency of Spontaneous Bowel Movements; Bowel Movement Timing; Stool Consistency; Abdominal Assessment; QOL Assessment	5 weeks	No