Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
NCT ID: NCT00504426
Last Updated: 2014-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2007-07-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
2
OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
3
OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
4
OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Interventions
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OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Eligibility Criteria
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Inclusion Criteria
* 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
46 Years
79 Years
FEMALE
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Katsuhisa Saito
Role: STUDY_DIRECTOR
Division of New Product Evaluation and Development
Locations
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Chubu Region, , Japan
Hokkaido Region, , Japan
Kanto Region, , Japan
Kinki Region, , Japan
Kyushu Region, , Japan
Countries
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Other Identifiers
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249-06-002OD
Identifier Type: -
Identifier Source: org_study_id
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