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A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis
Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVXT topical | Experimental | daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B), |
|
| Placebo (Vehicle) Topical | Placebo Comparator | two 8-week treatment periods separated by a 32-week rest period (Treatment Group C), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVXT topical | Drug | topical treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | Day 365 |
| Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail | Day 365 |
| Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novum Pharmaceutical Research Services | http://www.novumprs.com/contact | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services (Novum) | Pittsburgh | Pennsylvania | 15219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVXT Topical Treatment Group A | daily dosing for one 8-week treatment period NVXT topical: topical treatment |
| FG001 | NVXT Topical Treatment Group B | daily dosing for two 8-week treatment periods separated by a 32-week rest period NVXT topical: topical treatment |
| FG002 | Placebo (Vehicle) Topical Treatment Group C | two 8-week treatment periods separated by a 32-week rest period Placebo (Vehicle) Topical: Placebo (Vehicle) Topical |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVXT Topical Treatment Group A | daily dosing for one 8-week treatment period NVXT topical: topical treatment |
| BG001 | NVXT Topical Treatment Group B | daily dosing for two 8-week treatment periods separated by a 32-week rest period NVXT topical: topical treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis. | Posted | Count of Participants | Participants | Day 365 |
|
1 year, 1 month
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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 | NVXT Topical Treatment Group A | daily dosing for one 8-week treatment period NVXT topical: topical treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals U.S.A. Inc | +1 914-345-9001 | 6849 | Natalie.Yantovskiy@Taro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2018 | Nov 2, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 19, 2016 | Nov 2, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo (Vehicle) Topical | Drug | Placebo (Vehicle) Topical |
|
|
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail |
| Day 141 |
| Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | day 365 |
| Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | Day 141 |
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | day 365 |
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Day 281 |
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Day 141 |
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | day 365 |
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Day 281 |
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Day 141 |
| BG002 | Placebo (Vehicle) Topical Treatment Group C | two 8-week treatment periods separated by a 32-week rest period Placebo (Vehicle) Topical: Placebo (Vehicle) Topical |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
daily dosing for two 8-week treatment periods separated by a 32-week rest period NVXT topical: topical treatment |
| OG002 | Placebo (Vehicle) Topical Treatment Group C | two 8-week treatment periods separated by a 32-week rest period Placebo (Vehicle) Topical: Placebo (Vehicle) Topical |
|
|
|
| Primary | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 141 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail | 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis. | Posted | Count of Participants | Participants | Day 365 |
|
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 141 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis. | Posted | Count of Participants | Participants | day 365 |
|
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 20 subjects from Group A+B and 10 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 141 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis. | Posted | Count of Participants | Participants | day 365 |
|
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 281 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 141 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis. | Posted | Count of Participants | Participants | day 365 |
|
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 281 |
|
|
|
| Secondary | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures. | Posted | Count of Participants | Participants | Day 141 |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 19 |
| 64 |
| EG001 | NVXT Topical Treatment Group B | daily dosing for two 8-week treatment periods separated by a 32-week rest period NVXT topical: topical treatment | 0 | 62 | 0 | 62 | 14 | 62 |
| EG002 | Placebo (Vehicle) Topical Treatment Group C | two 8-week treatment periods separated by a 32-week rest period Placebo (Vehicle) Topical: Placebo (Vehicle) Topical | 0 | 58 | 1 | 58 | 13 | 58 |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting projectile | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Ureteric stenosis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Scrotal varicose veins | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA (19.1) | Systematic Assessment |
|
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Superiority |