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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 16, 2007

Last Updated Date

January 8, 2009

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00504426 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pain Due to Osteoporosis

Intervention ^†

Drug: OPC-249

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

46 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Drug Information Center

opc ctr@otsuka.jp

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00504426

Responsible Party

Katsuhisa Saito, OPCJ

Secondary IDs ^††

Study Sponsor ^†

Otsuka Pharmaceutical Co., Ltd.

Collaborators ^††

Investigators ^†

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

Information Provided By

Otsuka Pharmaceutical Co., Ltd.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.