Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00392223
First received: October 23, 2006
Last updated: January 5, 2010
Last verified: January 2010
Results First Received: June 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Azithromycin microspheres
Drug: minocycline-placebo capsules
Drug: Azithromycin microspheres-placebo
Drug: Minocycline capsules,

  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
Azithromycin 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
Minocycline 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)

Participant Flow:   Overall Study
    Azithromycin     Minocycline  
STARTED     58     60  
COMPLETED     49     47  
NOT COMPLETED     9     13  
Adverse Event                 5                 4  
Lost to Follow-up                 1                 4  
Protocol Violation                 0                 3  
Withdrawal by Subject                 3                 2  



  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
Azithromycin 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
Minocycline 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Total Total of all reporting groups

Baseline Measures
    Azithromycin     Minocycline     Total  
Number of Participants  
[units: participants]
  58     60     118  
Age, Customized  
[units: participants]
     
<18 years     10     17     27  
Between 18 and 44 years     48     43     91  
Gender  
[units: participants]
     
Female     35     36     71  
Male     23     24     47  



  Outcome Measures
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1.  Primary:   Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score   [ Time Frame: Baseline, Week 8 End of Treatment (EOT) ]

2.  Primary:   Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population   [ Time Frame: Baseline, Week 8 EOT ]

3.  Secondary:   Change From Baseline in Global Acne Grading System (GAGS) Score   [ Time Frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT ]

4.  Secondary:   Improvement of Global Acne Grading System (GAGS) Score   [ Time Frame: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT ]

5.  Secondary:   Change From Baseline in Acne Graded by Leeds Technique   [ Time Frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT ]

6.  Post-Hoc:   Number of Subjects With Mild, Moderate, and Severe Acne   [ Time Frame: Baseline, Week 8 End of Treatment (EOT) ]


  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 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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00392223     History of Changes
Other Study ID Numbers: A0661150
Study First Received: October 23, 2006
Results First Received: June 11, 2009
Last Updated: January 5, 2010
Health Authority: Italy: The Italian Medicines Agency