General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

Study Overview
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Brief Summary
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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.

Official Title
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General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

Conditions
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Chronic Constipation

Intervention / Treatment
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* Drug: AJG555


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AJG555<br>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. | Drug: AJG555<br>* Participants will receive 1 to 6 sachets daily per participants' age and conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AJG555, Constipation, Phase 3, Pediatric participants