Back to resultsPhase II 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
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
KWA-0711 High dose
KWA-0711 Low dose
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Secondary Outcome Measures
Change in fasting and postprandial blood glucose levels
Change in fasting and postprandial insulin levels
ECGs, vital signs, and clinical labs
Improvement of signs and symptoms associated with constipation
Full Information
NCT ID
NCT02343978
First Posted
January 16, 2015
Last Updated
May 18, 2017
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02343978
Brief Title
Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 26, 2014 (Actual)
Primary Completion Date
May 1, 2015 (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 safety and efficacy of KWA-0711 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
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KWA-0711 High dose
Arm Type
Experimental
Arm Title
KWA-0711 Low dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KWA-0711
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in fasting and postprandial blood glucose levels
Time Frame
2 weeks
Title
Change in fasting and postprandial insulin levels
Time Frame
2 weeks
Title
ECGs, vital signs, and clinical labs
Time Frame
2 weeks
Title
Improvement of signs and symptoms associated with constipation
Time Frame
2 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 (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
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
Learn more about this trial
Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)
We'll reach out to this number within 24 hrs