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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
History of Changes
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
No text entered.

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

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) ]
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Measure Type Secondary
Measure Title Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Measure Description Percent change in the amount of air the patient could exhale in 1 second
Time Frame from baseline to end of the 28-day treatment period (28 days)  
Safety Issue Yes  

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.
MITT

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

Measured Values
    Placebo     MP-376 120 mg QD     MP-376 240 mg QD     MP-376 240 mg BID  
Number of Participants Analyzed  
[units: participants]
 		  37     38     37     39  
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)  
[units: Percent change]
Least Squares Mean ± Standard Error 		  -2.36  ± 2.085     1.93  ± 2.114     2.56  ± 2.077     6.25  ± 2.081  


Statistical Analysis 1 for Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Groups [1] Placebo vs. MP-376 240 mg BID
Method [2] Mixed Models Analysis
P Value [3] 0.0026
Mean Difference (Final Values) [4] 8.61
95% Confidence Interval ( 3.05 to 14.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  LS Mean Difference Between MP-376 240 mg and Placebo groups
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

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) ]
  Show Outcome Measure 5

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


  Serious Adverse Events
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  Other Adverse Events
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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.


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
No text entered.  


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