Back to resultsGeneral Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AJG555
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation focused on measuring AJG555, Constipation, Phase 3, Pediatric participants
Eligibility Criteria
Inclusion Criteria:
Main Inclusion Criteria:
- Participants with chronic constipation
- Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
- Gender: N/A
Exclusion Criteria:
Main Exclusion Criteria:
- Participants with organic constipation or participants suspected of having organic constipation
- Participants with symptomatic constipation or participants suspected of having symptomatic constipation
- Participants with drug-induced constipation or participants suspected of having drug-induced constipation
Sites / Locations
- EA Pharma Trial Site #1
- EA Pharma Trial Site #2
- EA Pharma Trial Site #1
- EA Pharma Trial Site #1
- EA Pharma Trial Site #1
- EA Pharma Trial Site #2
- EA Pharma Trial Site #1
- EA Pharma Trial Site #2
- EA Pharma Trial Site #1
- EA Pharma Trial Site #1
- EA Pharma Trial Site #1
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AJG555
Arm Description
After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks.
Outcomes
Primary Outcome Measures
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
Secondary Outcome Measures
Change from the second week of the screening period in the number of SBMs at each week of the administration period
Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period
Change from the screening period in the number of SBMs at two weeks after the initiation of the administration
Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration
Number of days until SBM and CSBM
Change from the second week of the screening period in the total number of SBMs at each week of the administration period
Percentage of responders for SBM and CSBM at each week of the administration period
Stool consistency measured by the Bristol stool form scale
Usage of rescue medication
Number of pouches of AJG555 administered
Duration of administration of AJG555
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02961556
Brief Title
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Official Title
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
June 9, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EA Pharma Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
AJG555, Constipation, Phase 3, Pediatric participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AJG555
Arm Type
Experimental
Arm Description
After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
AJG555
Intervention Description
Participants will receive 1 to 6 sachets daily per participants' age and conditions.
Primary Outcome Measure Information:
Title
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
Time Frame
Screening; Week 2 of administration period
Secondary Outcome Measure Information:
Title
Change from the second week of the screening period in the number of SBMs at each week of the administration period
Time Frame
Screening; up to Week 12 of administration period
Title
Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period
Time Frame
Screening; up to Week 12 of administration period
Title
Change from the screening period in the number of SBMs at two weeks after the initiation of the administration
Time Frame
Screening; Week 2
Title
Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration
Time Frame
Screening; Week 2 of administration period
Title
Number of days until SBM and CSBM
Time Frame
up to Week 12 of administration period
Title
Change from the second week of the screening period in the total number of SBMs at each week of the administration period
Time Frame
Screening; up to Week 12 of administration period
Title
Percentage of responders for SBM and CSBM at each week of the administration period
Time Frame
up to Week 12 of administration period
Title
Stool consistency measured by the Bristol stool form scale
Time Frame
up to Week 12 of administration period
Title
Usage of rescue medication
Time Frame
up to Week 12 of administration period
Title
Number of pouches of AJG555 administered
Time Frame
up to Week 12 of administration period
Title
Duration of administration of AJG555
Time Frame
up to Week 12 of administration period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Main Inclusion Criteria:
Participants with chronic constipation
Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
Gender: N/A
Exclusion Criteria:
Main Exclusion Criteria:
Participants with organic constipation or participants suspected of having organic constipation
Participants with symptomatic constipation or participants suspected of having symptomatic constipation
Participants with drug-induced constipation or participants suspected of having drug-induced constipation
Facility Information:
Facility Name
EA Pharma Trial Site #1
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
EA Pharma Trial Site #2
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Hutyu
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #2
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #2
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Ōta
State/Province
Tokyo
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Hiroshima
Country
Japan
Facility Name
EA Pharma Trial Site #1
City
Saitama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
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