Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Patients who fulfill all of the following items

• Patients with primary osteoporosis

• Patients who have existing 1-4 vertebral fractures

• Patients with back pain persisting for one week or more

• Postmenopausal women between 46 and less than 80 years of age