General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2017-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EA Pharma Co., Ltd.

Criteria

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