Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00677365
First received: May 12, 2008
Last updated: May 8, 2012
Last verified: May 2012
Results First Received: September 4, 2011  
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: Cystic Fibrosis (CF)
Interventions: Drug: MP-376
Drug: Placebo

  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
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Reporting Groups
  Description
Placebo Placebo Group
MP-376 120 mg QD MP-376 120 mg Once Daily (QD) Group
MP-376 240 mg QD MP-376 240 mg Once Daily (QD) Group
MP-376 240 mg BID MP-376 240 mg Twice Daily (BID) Group

Participant Flow:   Overall Study
    Placebo     MP-376 120 mg QD     MP-376 240 mg QD     MP-376 240 mg BID  
STARTED     37     38     37     39  
COMPLETED     35     37     35     36  
NOT COMPLETED     2     1     2     3  
Adverse Event                 2                 1                 1                 2  
Withdrawal by Subject                 0                 0                 1                 0  
Other reason                 0                 0                 0                 1  



  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.
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Reporting Groups
  Description
Placebo Placebo Group
MP-376 120 mg QD MP-376 120 mg Once Daily (QD) Group
MP-376 240 mg QD MP-376 240 mg Once Daily (QD) Group
MP-376 240 mg BID MP-376 240 mg Twice Daily (BID) Group
Total Total of all reporting groups

Baseline Measures
    Placebo     MP-376 120 mg QD     MP-376 240 mg QD     MP-376 240 mg BID     Total  
Number of Participants  
[units: participants]
  37     38     37     39     151  
Age  
[units: years]
Mean ± Standard Deviation
  30.1  ± 9.94     28.0  ± 6.86     27.5  ± 9.05     29.2  ± 9.98     28.7  ± 9.02  
Gender  
[units: participants]
         
Female     18     18     16     14     66  
Male     19     20     21     25     85  
Region of Enrollment  
[units: Participants]
         
United States     30     32     30     32     124  
Europe     7     6     7     7     27  



  Outcome Measures
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1.  Primary:   Change in P. Aeruginosa Density   [ Time Frame: from baseline to end of treatment (28 days) ]

2.  Secondary:   Time to Administration of Other Anti-pseudomonal Antimicrobials   [ Time Frame: from baseline until final study visit (up to 56 days) ]

3.  Secondary:   Percent Change in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: from baseline to end of the 28-day treatment period (28 days) ]

4.  Secondary:   Change in FEV1 Percent Predicted   [ Time Frame: from baseline to the end of the treatment 28-day treatment period (28 days) ]

5.  Secondary:   Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)   [ Time Frame: from baseline to the end of the 28-day treatment period (28 days) ]

6.  Secondary:   Changes in Susceptability Patterns of Isolated Organisms   [ Time Frame: from baseline until the end of the 28-day treatment period (28 days) ]


  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: Jeff Loutit, MD; Chief Medical Officer
Organization: Rempex Pharmaceuticals Inc.
phone: 858.875.6665
e-mail: jloutit@rempexpharma.com


No publications provided by Mpex Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Mpex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00677365     History of Changes
Other Study ID Numbers: Mpex-204
Study First Received: May 12, 2008
Results First Received: September 4, 2011
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Dutch Health Care Inspectorate