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

NCT02063854 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 871

Last updated 2017-02-23

Study results available
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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.

Conditions

  • Involutional Osteoporosis

Interventions

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

Sponsors & Collaborators

  • EA Pharma Co., Ltd.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063854 on ClinicalTrials.gov