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Insmed Incorporated Message Board

  • iounothjing1 iounothjing1 Sep 5, 2013 6:32 PM Flag

    history changes Arikace® for Nontuberculous Mycobacteria sept 3 13

    Recruitment Information
    Status Recruiting
    Start date 2012-05
    Last follow-up date 2013-08 (Anticipated)

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    • second half of first post it would not let me do

      Recruitment Information
      Status Recruiting
      Start date 2012-05

      Last follow-up date 2013-09 (Anticipated)
      Primary completion date 2013-09 (Anticipated)

    • Thanks to zake1 for the complete post. I had posted the company had said in the last CC that it would be 1st qtr 2014 ( as Wedbush has been saying for 2 qtrs)....perhaps this info is more recent. Shorts and institutions are positioned. ................
      It won't be long now
      by zake1 • Sep 3, 2013 10:42 PM Flag
      Resource links provided by NLM:

      MedlinePlus related topics: Antibiotics Mycobacterial Infections

      Drug Information available for: Amikacin sulfate
      U.S. FDA Resources

      Further study details as provided by Insmed:

      Primary Outcome Measures: •Change in semi-quantitative mycobacterial culture results from baseline to end of treatment [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

      Secondary Outcome Measures: •Proportion of subjects with culture conversion to negative [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

      •Time to "rescue" anti-mycobacterial drugs [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

      •Change from baseline in 6-minute walk distance and oxygen saturation [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

      •Change from baseline in Patient Reported Outcomes [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

      •Evaluation of safety and tolerability [ Time Frame: For entire study duration ] [ Designated as safety issue: Yes ]

      Estimated Enrollment: 100
      Study Start Date: May 2012
      Estimated Study Completion Date: August 2013
      Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

 
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