General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

EA Pharma Co., Ltd.39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Constipation

Interventions

AJG555DRUG

Participants will receive 1 to 6 sachets daily per participants' age and conditions.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (11)

EA Pharma Trial Site #1

Yokohama, Kanagawa, Japan

EA Pharma Trial Site #2

Yokohama, Kanagawa, Japan

EA Pharma Trial Site #1

Bunkyo, Tokyo, Japan

EA Pharma Trial Site #1

Hutyu, Tokyo, Japan

Outcomes

Primary Outcomes

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 Outcomes

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

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

Change from the screening period in the number of SBMs at two weeks after the initiation of the administration

Time frame: Screening; Week 2

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

Number of days until SBM and CSBM

Time frame: 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

Time frame: Screening; up to Week 12 of administration period

Percentage of responders for SBM and CSBM at each week of the administration period

Time frame: up to Week 12 of administration period

Stool consistency measured by the Bristol stool form scale

Data from ClinicalTrials.gov

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