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Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356915
First received: July 25, 2006
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
Results First Received: October 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Onychomycosis, Toenail Onychomychosis, Toenail Fungus.
Interventions: Drug: Itraconazole 100mg capsules
Drug: Itraconazole 200mg tablets
Drug: Placebo tablets

  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
Subjects were recruited from clinics in the US, Canada, South America, Ecuador, Dominican Republic, Panama, and Honduras.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened prior to randomization and had to have a positive result from a mycological culture of their toe nail (ie, culture that was positive for dermatophytes). If the culture was negative, they were not randomized to receive treatment and were discontinued from the study.

Reporting Groups
  Description
Itraconazole Tablets Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Itraconazole Capsules Itraconazole 100 mg capsules
Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).

Participant Flow:   Overall Study
    Itraconazole Tablets     Itraconazole Capsules     Placebo Tablets  
STARTED     593     590     198  
COMPLETED     517     496     156  
NOT COMPLETED     76     94     42  
Non compliance                 1                 2                 1  
Protocol Violation                 2                 3                 2  
Withdrawal by Subject                 14                 14                 10  
Lack of Efficacy                 0                 0                 3  
Lost to Follow-up                 27                 34                 14  
Administrative Decision                 0                 0                 1  
Physician Decision                 0                 2                 0  
Adverse Event                 21                 31                 8  
Miscellaneous reasons                 11                 8                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Itraconazole Tablets Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Itraconazole Capsules Itraconazole 100 mg capsules
Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Total Total of all reporting groups

Baseline Measures
    Itraconazole Tablets     Itraconazole Capsules     Placebo Tablets     Total  
Number of Participants  
[units: participants]
 		  593     590     198     1381  
Age  
[units: years]
Mean ± Standard Deviation 		  47.1  ± 11.86     47  ± 12.67     49.2  ± 11.12     47.4  ± 12.13  
Gender  
[units: participants]
 		       
Female     441     440     153     1034  
Male     152     150     45     347  
Race (NIH/OMB) [1]
[units: Participants]
 		       
American Indian or Alaska Native     7     7     4     18  
Asian     5     4     2     11  
Native Hawaiian or Other Pacific Islander     0     1     0     1  
Black or African American     48     48     18     114  
White     512     493     169     1174  
Unknown or Not Reported     25     41     7     73  
Region of Enrollment  
[units: participants]
 		       
Panama     9     9     3     21  
United States     527     523     176     1226  
Canada     23     21     8     52  
Ecuador     6     8     3     17  
Honduras     9     9     3     21  
Dominican Republic     7     9     2     18  
South Africa     12     11     3     26  
[1] Subjects were permitted to select all choices from the list that apply to them with regard to race; ie, multiracial subjects would have checked more than one box and it would have been reported as such. Therefore the total number of subjects reported for race is greater than the number enrolled.



  Outcome Measures
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1.  Primary:   Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Primary:   Clinical and Mycological Cure of Target Toenail   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Clinical Improvement of the Target Toenail   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Clinical Improvement Compared to Placebo   [ Time Frame: 12 months ]
  Show Outcome Measure 4


  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 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 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.
unchecked Other disclosure agreement that restricts the right of the PI 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: David Angulo, MD
Organization: Barrier Therapeutics (now part of Stiefel, a GSK company)
phone: 786-999-7038
e-mail: david.a.angulo@stiefel.com


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00356915     History of Changes
Other Study ID Numbers: BT0300-302-INT
Study First Received: July 25, 2006
Results First Received: October 1, 2010
Last Updated: November 29, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration