A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative
study is designed to evaluate the efficacy and safety of once-monthly oral administration of
NE-58095 delayed release (DR) tablets for 12 months in participants with involutional
osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5
mg tablets once daily for 12 months are set as the control group.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Takeda
Collaborators:
Ajinomoto Pharmaceuticals Co., Ltd. EA Pharma Co., Ltd.