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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504426
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain Due to Osteoporosis
Intervention: Drug: OPC-249

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Placebo Placebo of OPC-249/vial
OPC-249 (30IU) 30 IU of OPC-249/vial
OPC-249 (60IU) 60 IU of OPC-249/vial
OPC-249 (120IU) 120 IU of OPC-249/vial

Participant Flow:   Overall Study
    Placebo   OPC-249 (30IU)   OPC-249 (60IU)   OPC-249 (120IU)
STARTED   32   23   22   24 
COMPLETED   29   22   18   24 
NOT COMPLETED   3   1   4   0 
Adverse Event                0                0                2                0 
Protocol Violation                1                1                2                0 
Withdrawal by Subject                2                0                0                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Placebo Placebo of OPC-249/vial
OPC-249 (30IU) 30 IU of OPC-249/vial
OPC-249 (60IU) 60 IU of OPC-249/vial
OPC-249 (120IU) 120 IU of OPC-249/vial
Total Total of all reporting groups

Baseline Measures
   Placebo   OPC-249 (30IU)   OPC-249 (60IU)   OPC-249 (120IU)   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   23   22   24   101 
[Units: Participants]
<=18 years   0   0   0   0   0 
Between 18 and 65 years   4   2   2   2   10 
>=65 years   28   21   20   22   91 
[Units: Years]
Mean (Standard Deviation)
 71.9  (6.0)   73.0  (5.1)   73.4  (5.9)   72.3  (5.9)   72.6  (5.9) 
[Units: Participants]
Female   32   23   22   24   101 
Male   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
Japan   32   23   22   24   101 

  Outcome Measures

1.  Primary:   Pain (Subjective Symptom)   [ Time Frame: Baseline and Week 4 ]

2.  Secondary:   Improvement Rate of Pain (Doctor's Judgment)   [ Time Frame: Baseline and Week 4 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: IMAOKA, Kyoji, Operatin Officer, Gemeral Manager
Organization: Headwuarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6361-7366

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT00504426     History of Changes
Other Study ID Numbers: 249-06-002OD
First Submitted: July 16, 2007
First Posted: July 20, 2007
Results First Submitted: July 1, 2013
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014