NCT02063854

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 871 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis. Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.

Conditions

• Involutional Osteoporosis

Interventions

Type	Name	Description
DRUG	NE-58095 IR	NE-58095 IR tablets
DRUG	NE-58095 IR Placebo	NE-58095 IR placebo-matching tablets
DRUG	NE-58095 DR	NE-58095 DR tablets
DRUG	NE-58095 DR Placebo	NE-58095 DR placebo-matching tablets

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-02-14
• Last updated: 2017-02-23
• Results posted: 2017-02-23

Locations

25 sites across 1 country: Japan