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Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302119
First received: February 21, 2011
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: July 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Onychomycosis of Toenails
Interventions: Drug: AN2690 Topical Solution, 5%
Drug: Solution Vehicle

  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 at forty-two investigative centers in the United States and Canada. The study population included men and women, 18 years of age and older who had distal subungual onychomycosis. The first subject visit occurred on February 2, 2011, and the last subject completed the Post Study Follow Up on February 20, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomized in a 2:1 ratio to receive AN2690 Topical Solution, 5% or Solution Vehicle to be applied once daily to all affected toenails throughout the 48-week treatment period.

Reporting Groups
  Description
AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution Vehicle

Solution Vehicle

Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks


Participant Flow:   Overall Study
    AN2690 Topical Solution, 5%   Solution Vehicle
STARTED   399   205 
COMPLETED   349   177 
NOT COMPLETED   50   28 
Withdrawal by Subject                30                20 
Lost to Follow-up                10                4 
Adverse Event                2                1 
Non-compliance                4                2 
Non-specific                4                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.
Analysis was performed using the intent-to-treat (ITT) population. Demographic characteristics were also analyzed using the Per Protocol (PP), Safety, and Post Study Follow Up (PSFU) populations, and were consistent with those of the ITT population. Safety analysis was performed using the Safety population.

Reporting Groups
  Description
AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution Vehicle

Solution Vehicle

Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Total Total of all reporting groups

Baseline Measures
   AN2690 Topical Solution, 5%   Solution Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 396   205   601 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (11.5)   55.4  (11.0)   55.5  (11.3) 
Gender 
[Units: Participants]
     
Female   73   31   104 
Male   323   174   497 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   57   30   87 
Not Hispanic or Latino   339   175   514 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   2   1   3 
Asian   11   2   13 
Native Hawaiian or Other Pacific Islander   2   1   3 
Black or African American   21   14   35 
White   355   183   538 
More than one race   0   0   0 
Unknown or Not Reported   5   4   9 
Region of Enrollment 
[Units: Participants]
     
United States   315   165   480 
Canada   81   40   121 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Completely Clear or Almost Clear Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Negative Mycology of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]


  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302119     History of Changes
Other Study ID Numbers: AN2690-ONYC-302
Study First Received: February 21, 2011
Results First Received: July 25, 2014
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada