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General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

NCT02961556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-10-24

No results posted yet for this study

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.

Conditions

  • Chronic Constipation

Interventions

DRUG

AJG555

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

Sponsors & Collaborators

  • EA Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-15
Primary Completion
2017-06-09
Completion
2017-08-04

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961556 on ClinicalTrials.gov