General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

Phase 3

Completed

• Conditions: Chronic Constipation
• Interventions: Drug: AJG555

• Registration Number: NCT02961556
• Lead Sponsor: EA Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Study Start: 2016-11-15
• Primary Completion: 2017-06-09
• Study Completion: 2017-08-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AJG555	AJG555	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Stool consistency measured by the Bristol stool form scale	up to Week 12 of administration period
Duration of administration of AJG555	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
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 number of complete SBMs (CSBMs) at each week of the administration period	Screening; up to Week 12 of administration period
Usage of rescue medication	up to Week 12 of administration period
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
Percentage of responders for SBM and CSBM at each week of the administration period	up to Week 12 of administration period
Number of pouches of AJG555 administered	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
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

Trial Locations

Locations (2)

EA Pharma Trial Site #1; 🇯🇵 Saitama, Japan

EA Pharma Trial Site #2; 🇯🇵 Shinjuku, Tokyo, Japan