drugset / Trial / NCT02961556
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AJG555 | Unknown | 1 unknown | Oral |
| Subject | AJG555 | Unknown | 6 unknown | Oral |