drugset / Trial / NCT02961556

General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

NCT02961556 ↗

Phase 3 Completed 39 enrolled EA Pharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

release “小児を対象とした第Ⅲ相試験(ベースライン対照非盲検試験)においても、主要評価項目である自発排便回数は、投与前と比較して統計学的に有意な増加を示しました。” eapharma.co.jp ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AJG555 Unknown 1 unknown Oral
Subject AJG555 Unknown 6 unknown Oral

Indications