- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504426
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Chubu Region, Japan
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Hokkaido Region, Japan
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Kanto Region, Japan
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Kinki Region, Japan
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Kyushu Region, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
|
Placebo Comparator: 1
|
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
|
Active Comparator: 3
|
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
|
Active Comparator: 4
|
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Subjective Symptom)
Time Frame: 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". |
Baseline and Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement Rate of Pain (Doctor's Judgment)
Time Frame: 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". |
Baseline and Week 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 249-06-002OD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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