Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 39 for:    Terbinafine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00443898
Recruitment Status : Completed
First Posted : March 7, 2007
Results First Posted : April 20, 2011
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Onychomycosis
Interventions Drug: terbinafine
Drug: Placebo
Enrollment 518
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks vehicle (placebo) applied once daily for 24 weeks Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks vehicle (placebo) applied once daily for 48 weeks
Period Title: Overall Study
Started 126 128 136 128
Completed 102 103 107 110
Not Completed 24 25 29 18
Reason Not Completed
Adverse Event             0             0             1             1
Lack of Efficacy             2             3             3             1
Protocol Violation             1             1             1             0
Withdrawal by Subject             11             10             10             6
Lost to Follow-up             10             10             14             10
Death             0             1             0             0
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w Total
Hide Arm/Group Description Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks vehicle (placebo) applied once daily for 24 weeks Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks vehicle (placebo) applied once daily for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 126 128 136 128 518
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 128 participants 136 participants 128 participants 518 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
107
  84.9%
101
  78.9%
116
  85.3%
100
  78.1%
424
  81.9%
>=65 years
19
  15.1%
27
  21.1%
20
  14.7%
28
  21.9%
94
  18.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 128 participants 136 participants 128 participants 518 participants
Female
25
  19.8%
29
  22.7%
26
  19.1%
27
  21.1%
107
  20.7%
Male
101
  80.2%
99
  77.3%
110
  80.9%
101
  78.9%
411
  79.3%
1.Primary Outcome
Title Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
Hide Description

Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.

and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as

  • Yes” if:

    • Mycological cure (negative KOH and negative culture for dermatophytes) and
    • No residual involvement of the target toenail
  • No” if otherwise
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description:
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
vehicle (placebo) applied once daily for 24 weeks
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
vehicle (placebo) applied once daily for 48 weeks
Overall Number of Participants Analyzed 126 128 136 128
Measure Type: Number
Unit of Measure: Percentage of Participants
0.79 0.78 1.47 0.00
2.Secondary Outcome
Title Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
Hide Description

Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.

Mycological cure was a composite binary variable defined as

  • Yes”if :

    • Negative microscopy and
    • Negative culture for dermatophytes
  • No” if otherwise.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description:
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
vehicle (placebo) applied once daily for 24 weeks
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
vehicle (placebo) applied once daily for 48 weeks
Overall Number of Participants Analyzed 126 128 136 128
Measure Type: Number
Unit of Measure: Percentage of Participants
10.32 6.25 15.44 3.13
3.Secondary Outcome
Title Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
Hide Description

Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.

Clinical effectiveness was a composite binary variable defined as

  • Yes” if

    • Mycological cure (negative KOH and negative culture for dermatophytes) and
    • = 10% residual involvement of the target toenail
  • No” if otherwise
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description:
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
vehicle (placebo) applied once daily for 24 weeks
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
vehicle (placebo) applied once daily for 48 weeks
Overall Number of Participants Analyzed 126 128 136 128
Measure Type: Number
Unit of Measure: Percentage of Participants
1.59 2.34 3.68 1.56
4.Secondary Outcome
Title Number of Participants Assessed With Adverse Events and Serious Adverse Events
Hide Description

An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.

A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.

Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description:
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
vehicle (placebo) applied once daily for 24 weeks
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
vehicle (placebo) applied once daily for 48 weeks
Overall Number of Participants Analyzed 126 124 135 128
Measure Type: Number
Unit of Measure: Participants
126 124 135 128
Time Frame 52 weeks
Adverse Event Reporting Description Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.
 
Arm/Group Title Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Hide Arm/Group Description Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks vehicle (placebo) applied once daily for 24 weeks Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks vehicle (placebo) applied once daily for 48 weeks
All-Cause Mortality
Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/126 (1.59%)   7/124 (5.65%)   7/135 (5.19%)   4/128 (3.13%) 
Cardiac disorders         
Cardiac failure congestive  1  0/126 (0.00%)  0/124 (0.00%)  0/135 (0.00%)  1/128 (0.78%) 
Gastrointestinal disorders         
Gastric ulcer perforation  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  0/128 (0.00%) 
General disorders         
Accidental death  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Chest discomfort  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  0/128 (0.00%) 
Infections and infestations         
Appendicitis  1  0/126 (0.00%)  0/124 (0.00%)  2/135 (1.48%)  0/128 (0.00%) 
Cellulitis  1  0/126 (0.00%)  0/124 (0.00%)  0/135 (0.00%)  1/128 (0.78%) 
Pneumonia  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Injury, poisoning and procedural complications         
Lower limb fracture  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  1/128 (0.78%) 
Tendon rupture  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Endometrial cancer  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Metastatic malignant melanoma  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Multiple myeloma  1  0/126 (0.00%)  0/124 (0.00%)  0/135 (0.00%)  1/128 (0.78%) 
Prostate cancer  1  1/126 (0.79%)  1/124 (0.81%)  1/135 (0.74%)  0/128 (0.00%) 
Nervous system disorders         
Cerebral haemorrhage  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  0/128 (0.00%) 
Convulsion  1  1/126 (0.79%)  0/124 (0.00%)  0/135 (0.00%)  0/128 (0.00%) 
Headache  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  0/128 (0.00%) 
Syncope  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Syncope vasovagal  1  0/126 (0.00%)  1/124 (0.81%)  0/135 (0.00%)  0/128 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/126 (0.00%)  0/124 (0.00%)  1/135 (0.74%)  0/128 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Terbinafine 24 w Vehicle 24 w Terbinafine 48 w Vehicle 48 w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/126 (27.78%)   38/124 (30.65%)   47/135 (34.81%)   56/128 (43.75%) 
General disorders         
Influenza like illness  1  2/126 (1.59%)  1/124 (0.81%)  0/135 (0.00%)  8/128 (6.25%) 
Infections and infestations         
Nasopharyngitis  1  7/126 (5.56%)  9/124 (7.26%)  18/135 (13.33%)  18/128 (14.06%) 
Upper respiratory tract infection  1  4/126 (3.17%)  6/124 (4.84%)  8/135 (5.93%)  8/128 (6.25%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  7/126 (5.56%)  7/124 (5.65%)  9/135 (6.67%)  10/128 (7.81%) 
Nervous system disorders         
Headache  1  23/126 (18.25%)  24/124 (19.35%)  23/135 (17.04%)  29/128 (22.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00443898     History of Changes
Other Study ID Numbers: CSFO327N2301
First Submitted: March 5, 2007
First Posted: March 7, 2007
Results First Submitted: January 19, 2011
Results First Posted: April 20, 2011
Last Update Posted: May 3, 2012