drugset / Trial / NCT02063854
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NE-58095 DR | Unknown | 25 mg | Oral |
| Subject | NE-58095 DR | Unknown | 37.5 mg | Oral |
| Comparator | Risedronate | Small molecule | 2.5 mg | — |
| Comparator | Risedronate | Small molecule | 25 mg | — |
| Comparator | Risedronate | Small molecule | 37.5 mg | — |