Back to resultsPhase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
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 treatment trial for Chronic Constipation focused on measuring Chronic Constipation, CC
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
KWA-0711 High dose
KWA-0711 Low dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
Secondary Outcome Measures
Complete SBM (CSBM) frequency and responder rate
SBM frequency and responder rate
Time to first SBM after the initial dose
Stool consistency
Degree of straining
Abdominal bloating and discomfort
Use of rescue medications
Global assessment of constipation severity
Japanese version of IBS-QOL
Global assessment of treatment effectiveness
Satisfaction rating for the condition of bowel movements
Adverse events, ECGs, vital signs, and clinical labs
Full Information
NCT ID
NCT02281630
First Posted
October 22, 2014
Last Updated
May 18, 2017
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02281630
Brief Title
Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
Official Title
Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2014 (Actual)
Primary Completion Date
April 28, 2015 (Actual)
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
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) 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, CC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KWA-0711 High dose
Arm Type
Experimental
Arm Title
KWA-0711 Low dose
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
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Complete SBM (CSBM) frequency and responder rate
Time Frame
4 weeks
Title
SBM frequency and responder rate
Time Frame
4 weeks
Title
Time to first SBM after the initial dose
Time Frame
4 weeks
Title
Stool consistency
Time Frame
4 weeks
Title
Degree of straining
Time Frame
4 weeks
Title
Abdominal bloating and discomfort
Time Frame
4 weeks
Title
Use of rescue medications
Time Frame
4 weeks
Title
Global assessment of constipation severity
Time Frame
4 weeks
Title
Japanese version of IBS-QOL
Time Frame
4 weeks
Title
Global assessment of treatment effectiveness
Time Frame
4 weeks
Title
Satisfaction rating for the condition of bowel movements
Time Frame
4 weeks
Title
Adverse events, ECGs, vital signs, and clinical labs
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuro Takei
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30056028
Citation
Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25. Erratum In: Lancet Gastroenterol Hepatol. 2018 Sep;3(9):e4.
Results Reference
derived
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Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
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