General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

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 Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: AJG555

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • EA Pharma Trial Site #1
  • Saitama, Japan
    • EA Pharma Trial Site #1
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • EA Pharma Trial Site #1
    • Yokohama, Kanagawa, Japan
      • EA Pharma Trial Site #2
  • Tokyo
    • Bunkyo, Tokyo, Japan
      • EA Pharma Trial Site #1
    • Hutyu, Tokyo, Japan
      • EA Pharma Trial Site #1
    • Setagaya, Tokyo, Japan
      • EA Pharma Trial Site #1
    • Setagaya, Tokyo, Japan
      • EA Pharma Trial Site #2
    • Shinjuku, Tokyo, Japan
      • EA Pharma Trial Site #1
    • Shinjuku, Tokyo, Japan
      • EA Pharma Trial Site #2
    • Ōta, Tokyo, Japan
      • EA Pharma Trial Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: AJG555; Participants will receive 1 to 6 sachets daily per participants' age and conditions.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2016
• Primary Completion (ACTUAL): June 9, 2017
• Study Completion (ACTUAL): August 4, 2017

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (ESTIMATE): November 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Constipation; Phase 3; Pediatric participants; AJG555
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: AJG555/CT2