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This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks |
|
| 2 | Placebo Comparator | vehicle (placebo) applied once daily for 48 weeks |
|
| 3 | Experimental | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks |
|
| 4 | Placebo Comparator | vehicle (placebo) applied once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| terbinafine | Drug | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | 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:
| 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure was a composite binary variable defined as "Yes"if :
| 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Boni Elewski | Birmingham | Alabama | 35233 | United States | ||
| Dr. Stacy Smith |
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| ID | Title | Description |
|---|---|---|
| FG000 | Terbinafine 24 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks |
| FG001 | Vehicle 24 w | vehicle (placebo) applied once daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | vehicle (placebo) applied once daily for 48 weeks |
|
| terbinafine | Drug | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks |
|
|
| Placebo | Drug | vehicle (placebo) applied once daily for 24 weeks |
|
| Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | 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
| 52 weeks |
| Number of Participants Assessed With Adverse Events and Serious Adverse Events | 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. | 52 weeks |
| San Diego |
| California |
| 92123 |
| United States |
| Dr. James Swinehart | Denver | Colorado | 80210 | United States |
| Dr. David G. Armstrong | North Chicago | Illinois | 60064 | United States |
| Dr. Kevin Terry | Lutherville | Maryland | 21093 | United States |
| Dr. Anthony Puopolo | Milford | Massachusetts | 01757 | United States |
| Dr. John Fenyk | Chaska | Minnesota | 55318 | United States |
| Dr. Joel Schlessinger | Omaha | Nebraska | 68144 | United States |
| Dr. AnneMarie Uliasz | New York | New York | 10029 | United States |
| Dr. Willard Niemi | Raleigh | North Carolina | 27615 | United States |
| Dr. Diane Baker | Lake Oswego | Oregon | 97035 | United States |
| Dr. John Barnes | Portland | Oregon | 97205 | United States |
| Dr. Harry Penny | Altoona | Pennsylvania | 16602 | United States |
| Dr. Lawrence Parish | Philadelphia | Pennsylvania | 19103 | United States |
| Dr. Cynthia Strout | Mt. Pleasant | South Carolina | 29464 | United States |
| Dr. Teresa Coats | Austin | Texas | 78705 | United States |
| Dr. Scott J. Ashton | Dallas | Texas | 75243 | United States |
| Dr. Amit Pandya | Dallas | Texas | 75390-8802 | United States |
| Dr. Lawrence Harkless | San Antonio | Texas | 78207 | United States |
| Dr. Robert Shouey | Harrisonburg | Virginia | 22801 | United States |
| Novartis Investigative Site | Various Cities | Canada |
| Novartis Investigative Site | Various Cities | Iceland |
| FG002 | Terbinafine 48 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks |
| FG003 | Vehicle 48 w | vehicle (placebo) applied once daily for 48 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Terbinafine 24 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks |
| BG001 | Vehicle 24 w | vehicle (placebo) applied once daily for 24 weeks |
| BG002 | Terbinafine 48 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks |
| BG003 | Vehicle 48 w | vehicle (placebo) applied once daily for 48 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | 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:
| 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). | Posted | Number | Percentage of Participants | 52 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure was a composite binary variable defined as "Yes"if :
| 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). | Posted | Number | Percentage of Participants | 52 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | 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
| 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). | Posted | Number | Percentage of Participants | 52 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Assessed With Adverse Events and Serious Adverse Events | 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. | 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. | Posted | May 2011 | Number | Participants | 52 weeks |
|
52 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Terbinafine 24 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks | 2 | 126 | 35 | 126 | ||
| EG001 | Vehicle 24 w | vehicle (placebo) applied once daily for 24 weeks | 7 | 124 | 38 | 124 | ||
| EG002 | Terbinafine 48 w | Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks | 7 | 135 | 47 | 135 | ||
| EG003 | Vehicle 48 w | vehicle (placebo) applied once daily for 48 weeks | 4 | 128 | 56 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Accidental death | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| D005533 | Foot Dermatoses |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
vehicle (placebo) applied once daily for 48 weeks |
|
|
| OG003 |
| Vehicle 48 w |
vehicle (placebo) applied once daily for 48 weeks |
|
|
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks |
| OG003 | Vehicle 48 w | vehicle (placebo) applied once daily for 48 weeks |
|
|