Chronic Constipation
Conditions
Keywords
AJG555, Constipation, Phase 3, Pediatric participants
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.
Interventions
DRUGAJG555
Participants will receive 1 to 6 sachets daily per participants' age and conditions.
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Screening; Week 2 of administration period |
Secondary
| Measure | Time frame |
|---|---|
| Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period | Screening; up to Week 12 of administration period |
| Change from the screening period in the number of SBMs at two weeks after the initiation of the administration | Screening; Week 2 |
| Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration | Screening; Week 2 of administration period |
| Number of days until SBM and CSBM | up to Week 12 of administration period |
| Change from the second week of the screening period in the total number of SBMs at each week of the administration period | Screening; up to Week 12 of administration period |
| Change from the second week of the screening period in the number of SBMs at each week of the administration period | Screening; up to Week 12 of administration period |
| Stool consistency measured by the Bristol stool form scale | up to Week 12 of administration period |
| Usage of rescue medication | up to Week 12 of administration period |
| Number of pouches of AJG555 administered | up to Week 12 of administration period |
| Duration of administration of AJG555 | up to Week 12 of administration period |
| Percentage of responders for SBM and CSBM at each week of the administration period | up to Week 12 of administration period |
Countries
Japan
Outcome results
None listed