Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if this will happen earlier than 4th day of treatment. |
|
| Arm B | Active Comparator | ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if this will happen earlier than 5th day of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angal, lozenges [menthol], | Drug | Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Sore Throat According to TSS Score | TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms
0 pts : <37.5 °С;
| 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 50% Reduction Tss SCORE | Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2 | day 4 |
| Change From Baseline in TSS Total Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandoz | Sandoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Arkhangelsk | 163000 | Russia | |||
| Sandoz Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
228 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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ANGAL | Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment. |
| FG001 | ANTIANGIN |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2016 | May 3, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ANTI-ANGIN® FORMULA | Drug | 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution. |
|
Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale:
0 : no symptoms
0 pts : <37.5 °С;
| baseline and day 4 |
| Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient) | only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set | 5 days |
| Number of Participants Who Fully Recovered up to Day 5 | Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) | 4 days for Angal, 5 days for AntiAngin |
| Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | 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. | baseline, day 4 |
| 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 ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment. |
|
| Intent to Treat Population ITT |
|
| Per Protocol Population PP |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ANGAL | Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment. |
| BG001 | ANTIANGIN | Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment. |
| BG002 | 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, Continuous | ITT | Mean | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | ITT | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | 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 | Percentage of Participants Without Sore Throat According to TSS Score | TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms
0 pts : <37.5 °С;
| ITT, only patients with measurements were included (115 for Angal, and 112 for Antiangin) | Posted | Number | percentage of participants | 4 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 50% Reduction Tss SCORE | Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2 | PP set was considered for the analysis, however only the number of patients with complete data at visit 2 were considered for the analysis | Posted | Number | 95% Confidence Interval | percentage of participants | day 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in TSS Total Score | Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale: 0 : no symptoms
0 pts : <37.5 °С;
| PP | Posted | Mean | Full Range | unit on a scale | baseline and day 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient) | only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set | PP | Posted | Mean | Standard Error | days | 5 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Fully Recovered up to Day 5 | Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2) | PP | Posted | Number | participants | 4 days for Angal, 5 days for AntiAngin |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . | 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. | PP, participants with measure | Posted | Mean | Standard Deviation | millimeters | baseline, day 4 |
|
|
5 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANGAL | Patients received Angal, lozenges, per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution, if happened earlier than 4th day of treatment. | 0 | 115 | 0 | 115 | 6 | 115 |
| EG001 | ANTIANGIN | Patients received ANTIANGIN ® FORMULA, 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution, if happened earlier than 5th day of treatment. | 0 | 113 | 0 | 113 | 12 | 113 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Tachicardia | Cardiac disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| epigastric discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| hypoesthesia oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| pyrexia | General disorders | Systematic Assessment |
| ||
| ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| red blood cell analysis abnormal | Investigations | Systematic Assessment |
| ||
| dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pharyngeal hypoesthesia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| sore throat TSS score 2 |
|
| sore throat TSS score 3 |
|
|
| Participants |
|
|
|
|
|
|
|