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Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00443820
First received: March 2, 2007
Last updated: March 22, 2011
Last verified: March 2011
Results First Received: January 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Onychomycosis
Interventions: Drug: terbinafine
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
This randomized, double -blind, vehicle -controlled, multicenter, parallel group study was designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine hydrogen chloride 10% topical solution (TTS10%) applied daily in patients with toenail onychomycosis. Started 07 DEC 2006 and ending 27 JUN 2008.

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
Terbinafine 24 Weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle 24 Weeks Vehicle (placebo) for 24 weeks
Terbinafine 48 Weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle 48 Weeks Vehicle (placebo) for 48 weeks

Participant Flow:   Overall Study
    Terbinafine 24 Weeks     Vehicle 24 Weeks     Terbinafine 48 Weeks     Vehicle 48 Weeks  
STARTED     133     130     135     128  
Safety Population     131 [1]   129     134     126  
COMPLETED     112     111 [2]   117     111  
NOT COMPLETED     21     19     18     17  
Adverse Event                 1                 1                 0                 0  
Lack of Efficacy                 3                 2                 1                 1  
Protocol Violation                 2                 1                 2                 1  
Withdrawal by Subject                 6                 7                 8                 9  
Lost to Follow-up                 9                 8                 6                 5  
Administrative problems                 0                 0                 0                 1  
Death                 0                 0                 1                 0  
[1] Participants who received study drug and had at least one post-baseline safety assessment.
[2] A participant from this gr. discont'ed due to renal failure, was counted as an AE and also as a SAE.



  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
Terbinafine 24 Weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle 24 Weeks Vehicle (placebo) for 24 weeks
Terbinafine 48 Weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle 48 Weeks Vehicle (placebo) for 48 weeks
Total Total of all reporting groups

Baseline Measures
    Terbinafine 24 Weeks     Vehicle 24 Weeks     Terbinafine 48 Weeks     Vehicle 48 Weeks     Total  
Number of Participants  
[units: participants]
  133     130     135     128     526  
Age  
[units: participants]
         
<=18 years     0     0     0     1     1  
Between 18 and 65 years     93     103     95     97     388  
>=65 years     40     27     40     30     137  
Gender  
[units: participants]
         
Female     34     39     41     35     149  
Male     99     91     94     93     377  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks   [ Time Frame: 52 weeks ]

2.  Secondary:   Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks   [ Time Frame: 52 weeks ]

3.  Secondary:   Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks   [ Time Frame: 52 weeks ]

4.  Secondary:   Safety and Tolerability Assessed by the Number of Participants With Adverse Events   [ Time Frame: 52 weeks ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00443820     History of Changes
Other Study ID Numbers: CSFO327N2302
Study First Received: March 2, 2007
Results First Received: January 19, 2011
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices