Back to resultsA Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KWA-0711
Placebo
Sponsored by
About this trial
This is an interventional trial for Chronic Constipation focused on measuring Chronic Constipation, Constipation, Functional gastrointestinal disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
KWA-0711 Dose1
KWA-0711 Dose2
KWA-0711 Dose3
KWA-0711 Dose4
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improvement of signs and symptoms associated with constipation
Frequency of Spontaneous Bowel Movements
Bowel Movement Timing
Stool Consistency
Abdominal Assessment
QOL Assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT01938196
First Posted
August 27, 2013
Last Updated
November 11, 2014
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01938196
Brief Title
A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Chronic Constipation, Constipation, Functional gastrointestinal disorders
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
KWA-0711 Dose1
Arm Type
Experimental
Arm Title
KWA-0711 Dose2
Arm Type
Experimental
Arm Title
KWA-0711 Dose3
Arm Type
Experimental
Arm Title
KWA-0711 Dose4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KWA-0711
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Improvement of signs and symptoms associated with constipation
Description
Frequency of Spontaneous Bowel Movements
Bowel Movement Timing
Stool Consistency
Abdominal Assessment
QOL Assessment
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation
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