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Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

This study has been completed.
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT01097005
First received: February 26, 2010
Last updated: July 28, 2016
Last verified: March 2015
Results First Received: June 17, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Mycobacterium Infections, Atypical

  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
Patients will be registered using a central registration system. The investigators will register eligible patients with the registration center via FAX by 7 days after initiation of clarithromycin treatment.

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
Clarithromycin Those with an exposure

Participant Flow:   Overall Study
    Clarithromycin  
STARTED     466 [1]
Analysis of Safety     441 [2]
Analysis of NTM Lung Disease     340 [3]
Analysis of Bacilli Negative Conversion     285 [4]
Analysis of CGI     249 [5]
COMPLETED     101  
NOT COMPLETED     365  
Case Report Form not collected                 18  
Subjects cannot visit the hospital                 1  
Poor medication compliance                 1  
No examination data available                 244  
Deviation from exclusion criteria                 37  
Adverse Event                 14  
Discontinuance by complication                 50  
[1] number of participants who were enrolled for this study.
[2] number of participants who could be measured for Adverse Events
[3] number of participants who contributed to the Baseline data
[4] number of participants who were analysed for bacilli negative conversion
[5] number of participants who were measured for Clinical Global Improvement (CGI)



  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
Clarithromycin Those with an exposure

Baseline Measures
    Clarithromycin  
Number of Participants  
[units: participants]
  340  
Age, Customized  
[units: participants]
 
<45 years     15  
45-64 years     136  
65-74 years     126  
>=75 years     62  
unknown     1  
Gender, Customized  
[units: participants]
 
Female     256  
Male     83  
unknown     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bacilli Negative Conversion Rate   [ Time Frame: During the treatment with clarithromycin, from 40 days to 1232 days ]

2.  Secondary:   Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator   [ Time Frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days ]

3.  Secondary:   Bacteriological Relapse Related to Duration of Clarithromycin Administration   [ Time Frame: 36 months ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Takao Miki, Medical Affairs
Organization: Mylan EPD Japan
e-mail: takao.miki@mylan.com



Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01097005     History of Changes
Other Study ID Numbers: P10-765
Study First Received: February 26, 2010
Results First Received: June 17, 2015
Last Updated: July 28, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare