Back to resultsA Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
Primary Purpose
Chronic Idiopathic Constipation
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KWA-0711
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Constipation focused on measuring Chronic Idiopathic Constipation (CIC), Constipation, Functional gastrointestinal disorders
Eligibility Criteria
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
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Drug:KWA-0711 dose 1
Drug:KWA-0711 dose 2
Drug:KWA-0711 dose 3
Drug:KWA-0711 dose 4
Drug: Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improvement of signs and symptoms associated with constipation
Secondary Outcome Measures
Full Information
NCT ID
NCT01600001
First Posted
May 14, 2012
Last Updated
October 29, 2013
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01600001
Brief Title
A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
Keywords
Chronic Idiopathic Constipation (CIC), Constipation, Functional gastrointestinal disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug:KWA-0711 dose 1
Arm Type
Experimental
Arm Title
Drug:KWA-0711 dose 2
Arm Type
Experimental
Arm Title
Drug:KWA-0711 dose 3
Arm Type
Experimental
Arm Title
Drug:KWA-0711 dose 4
Arm Type
Experimental
Arm Title
Drug: 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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
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