Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
- Registration Number
- NCT00504426
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 101
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 OPC-249 - 2 OPC-249 - 3 OPC-249 - 1 OPC-249 -
- Primary Outcome Measures
Name Time Method Pain (Subjective Symptom) Baseline and Week 4 Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.
Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable".
- Secondary Outcome Measures
Name Time Method Improvement Rate of Pain (Doctor's Judgment) Baseline and Week 4 Percentage of participants qualified for improvement of pain by doctor's judgement.
Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.
Improvement defind by "stopped or almost stopped" or "alleviated".