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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00504426
First received: July 16, 2007
Last updated: December 24, 2013
Last verified: December 2013
Results First Received: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain Due to Osteoporosis
Intervention: Drug: OPC-249

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
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
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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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  32     23     22     24     101  
Age  
[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  
Age  
[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  
Gender  
[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
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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
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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
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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


No publications provided


Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00504426     History of Changes
Other Study ID Numbers: 249-06-002OD
Study First Received: July 16, 2007
Results First Received: July 1, 2013
Last Updated: December 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare