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

This study is currently recruiting participants.

Verified by Otsuka Pharmaceutical Co., Ltd., January 2009

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00504426

Purpose

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.

Condition	Intervention	Phase
Pain Due to Osteoporosis	Drug: OPC-249	Phase II

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dose-Ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Pain (subjective symptom) [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pain (subjective symptom) [ Time Frame: Weeks 1, 2, and 3 ] [ Designated as safety issue: Yes ]
Pain (doctor's judgment) [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
QOL [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: OPC-249 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
2: Active Comparator	Drug: OPC-249 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
3: Active Comparator	Drug: OPC-249 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
4: Active Comparator	Drug: OPC-249 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)

Eligibility

Ages Eligible for Study:	46 Years to 79 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504426

Contacts

Contact: Drug Information Center

opc ctr@otsuka.jp

Locations

Japan
	Recruiting
Hokkaido Region, Japan
	Recruiting
Kanto Region, Japan
Contact: -
	Recruiting
Chubu Region, Japan
	Recruiting
Kinki Region, Japan
	Recruiting
Kyushu Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

More Information

Responsible Party:	OPCJ ( Katsuhisa Saito )
Study ID Numbers:	249-06-002OD
Study First Received:	July 16, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00504426
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Pain
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009