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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AJG555 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AJG555 | Drug | Participants will receive 1 to 6 sachets daily per participants' age and conditions. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period |
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Inclusion Criteria:
Main Inclusion Criteria:
Exclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EA Pharma Trial Site #1 | Yokohama | Kanagawa | Japan | |||
| EA Pharma Trial Site #2 |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Percentage of responders for SBM and CSBM at each week of the administration period | 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 |
| Yokohama |
| Kanagawa |
| Japan |
| EA Pharma Trial Site #1 | Bunkyo | Tokyo | Japan |
| EA Pharma Trial Site #1 | Hutyu | Tokyo | Japan |
| EA Pharma Trial Site #1 | Ōta-ku | Tokyo | Japan |
| EA Pharma Trial Site #1 | Setagaya City | Tokyo | Japan |
| EA Pharma Trial Site #2 | Setagaya City | Tokyo | Japan |
| EA Pharma Trial Site #1 | Shinjuku | Tokyo | Japan |
| EA Pharma Trial Site #2 | Shinjuku | Tokyo | Japan |
| EA Pharma Trial Site #1 | Hiroshima | Japan |
| EA Pharma Trial Site #1 | Saitama | Japan |