Pain Due to Osteoporosis Clinical Trial
Official title:
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | May 2009 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 46 Years to 79 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain (Subjective Symptom) | 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". |
Baseline and Week 4 | No |
| Secondary | Improvement Rate of Pain (Doctor's Judgment) | 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". |
Baseline and Week 4 | No |