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Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01278394
First received: January 14, 2011
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: July 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Onychomycosis
Intervention: Drug: AN2690 Solution, 5.0%

  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 screened and enrolled and two investigative sites in Mexico. The study population included men and women of any race, 18-65 years of age who had distal, subungual onychomycosis of the great toenail. The first subject visit occurred on March 28, 2007, and the last subject visit occurred on July 11, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects in Cohort 3 were treated with 5.0% AN2690 Solution.

Reporting Groups
  Description
AN2690 Solution, 5.0% AN2690 Solution, 5.0%: Once daily application for 360 days

Participant Flow:   Overall Study
    AN2690 Solution, 5.0%  
STARTED     29  
COMPLETED     28  
NOT COMPLETED     1  
Lost to Follow-up                 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.
All analyses were performed using the intent-to-treat (ITT) population.

Reporting Groups
  Description
AN2690 Solution, 5.0% AN2690 Solution, 5.0%: Once daily application for 360 days

Baseline Measures
    AN2690 Solution, 5.0%  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     0  
Gender  
[units: participants]
 
Female     11  
Male     18  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     29  
Not Hispanic or Latino     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Mexico     29  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 10.15  



  Outcome Measures
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1.  Primary:   Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360   [ Time Frame: Day 360 ]

2.  Secondary:   Clear Nail Growth of the Targeted Toenail   [ Time Frame: Day 360 ]

3.  Secondary:   Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline   [ Time Frame: Day 90 ]

4.  Secondary:   Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline   [ Time Frame: Day 180 ]

5.  Secondary:   Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline   [ Time Frame: Day 270 ]

6.  Secondary:   Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline   [ Time Frame: Day 360 ]

7.  Secondary:   Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG   [ Time Frame: Baseline to 360 ]


  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: Sheryl Baldwin, RN/Associate Director
Organization: Anacor Pharmaceuticals, Inc.
phone: 650-223-8597
e-mail: clinicaltrials@anacor.com


No publications provided


Responsible Party: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01278394     History of Changes
Other Study ID Numbers: AN2690-ONYC-201 Cohort 3
Study First Received: January 14, 2011
Results First Received: July 25, 2014
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health