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The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angal S (Arm A) | Experimental | Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
|
| ANTI-ANGIN® FORMULA (Arm B) | Active Comparator | Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angal S, topical spray [Menthol] | Drug | 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | 4 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥50% TSS Total Score Reduction | Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz | Sandoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Arkhangelsk | 163000 | Russia | |||
| Sandoz Investigational Site |
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229 patients in total were included
The trial included a screening period, up to 5 days active treatment, and follow-up visit. The patients had to visit the trial site up to 3 times.
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| ID | Title | Description |
|---|---|---|
| FG000 | Angal S (Arm A) | Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| FG001 | ANTI-ANGIN® FORMULA (Arm B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2016 | May 3, 2018 |
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| ANTI-ANGIN® FORMULA, topical metered spray | Drug | 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution |
|
| 4 days |
| Change From Baseline in TSS Total Score | Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | 4 days |
| Number of Participants Who Fully Recovered | Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) | Group A: 4 days Group B: 5 days |
| Change in the Sore Throat Intensity by 100 mm VAS | Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity. | 4 days |
| Period of Time Required for Disappearance of the Disease Symptoms | A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome. | 5 Days |
| Moscow |
| 105018 |
| Russia |
| Sandoz Investigational Site | Moscow | 115280 | Russia |
| Sandoz Investigational Site | Moscow | 119192 | Russia |
| Sandoz Investigational Site | Moscow | 127015 | Russia |
| Sandoz Investigational Site | Moscow | 135215 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 188643 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 191036 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 196143 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 197706 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 198207 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 199178 | Russia |
| Sandoz Investigational Site | Saint Petersburg | 199226 | Russia |
| Sandoz Investigational Site | Stavropol | 355000 | Russia |
Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| Per Protocol Population |
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| Safety Population |
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| ITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Angal S (Arm A) | Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| BG001 | ANTI-ANGIN® FORMULA (Arm B) | Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With a ≥50% TSS Total Score Reduction | Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | 4 days |
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| Secondary | Change From Baseline in TSS Total Score | Change from baseline in TSS total score completed by the Investigator as compared to the baseline. The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | ITT population | Posted | Median | Full Range | units on a scale | 4 days |
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| Secondary | Number of Participants Who Fully Recovered | Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) | ITT population | Posted | Count of Participants | Participants | No | Group A: 4 days Group B: 5 days |
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| Secondary | Change in the Sore Throat Intensity by 100 mm VAS | Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity. | ITT population | Posted | Mean | Standard Deviation | mm | 4 days |
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| Secondary | Period of Time Required for Disappearance of the Disease Symptoms | A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial-for patients who have achieved the corresponding outcome. | ITT Population (only cases with disappearance of symptoms within 5 days) | Posted | Mean | Standard Deviation | Days | 5 Days |
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| Primary | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms: throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15. | ITT Population | Posted | Number | Percentage of Participants | 4 Days |
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From signing informed consent (Day 1) until completion of the trial (Day 7).
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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 | Angal S (Arm A) | Patients received Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | 0 | 114 | 0 | 114 | 7 | 114 |
| EG001 | ANTI-ANGIN® FORMULA (Arm B) | Patients received ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution | 0 | 115 | 0 | 115 | 11 | 115 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However Novartis does not prohibit any inversdtigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Sandoz | +41613241111 | Sandoz.email@sandoz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2017 | May 3, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008610 | Menthol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
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