Trial · NCT03095508
Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
NCT03095508, Phase 3, Completed, Sandoz; results first posted 2019-03-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat. Trials, record NCT03095508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
- NCT number
- NCT03095508
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 229 participants, actual
- Lead sponsor
- Sandoz
- Conditions
- Sore Throat
- Interventions
- Angal S, topical spray [Menthol], ANTI-ANGIN® FORMULA, topical metered spray
- First posted
- 2017-03-29
- Last updated
- 2019-03-21
- Results first posted
- 2019-03-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | 4 Days | 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. |
| Secondary | Percentage of Participants With a ≥50% TSS Total Score Reduction | 4 days | 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. |
| Secondary | Change From Baseline in TSS Total Score | 4 days | 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. |
| Secondary | Number of Participants Who Fully Recovered | Group A: 4 days Group B: 5 days | 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) |
| Secondary | Change in the Sore Throat Intensity by 100 mm VAS | 4 days | 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. |
| Secondary | Period of Time Required for Disappearance of the Disease Symptoms | 5 Days | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Participants With a ≥50% TSS Total Score Reduction | 4 days | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in TSS Total Score | 4 days | ITT population | units on a scale | MEDIAN |
| SECONDARY | Number of Participants Who Fully Recovered | Group A: 4 days Group B: 5 days | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Sore Throat Intensity by 100 mm VAS | 4 days | ITT population | mm | MEAN |
| SECONDARY | Period of Time Required for Disappearance of the Disease Symptoms | 5 Days | ITT Population (only cases with disappearance of symptoms within 5 days) | Days | MEAN |
| PRIMARY | Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) | 4 Days | ITT Population | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a ≥50% TSS Total Score Reduction | Angal S (Arm A) | 96.49 | 95% Confidence Interval 91.26 to 99.04 | percentage of participants | |
| Percentage of Participants With a ≥50% TSS Total Score Reduction | ANTI-ANGIN® FORMULA (Arm B) | 98.26 | 95% Confidence Interval 93.86 to 99.79 | percentage of participants | |
| Change From Baseline in TSS Total Score | Angal S (Arm A) | -6 | Full Range -11 to 0 | units on a scale | |
| Change From Baseline in TSS Total Score | ANTI-ANGIN® FORMULA (Arm B) | -6 | Full Range -10 to 0 | units on a scale | |
| Number of Participants Who Fully Recovered | Angal S (Arm A) | 106 | Participants | ||
| Number of Participants Who Fully Recovered | ANTI-ANGIN® FORMULA (Arm B) | 107 | Participants | ||
| Change in the Sore Throat Intensity by 100 mm VAS | Angal S (Arm A) | Baseline (Visit 1) | 64.76 | Standard Deviation 16.29 | mm |
| Change in the Sore Throat Intensity by 100 mm VAS | ANTI-ANGIN® FORMULA (Arm B) | Baseline (Visit 1) | 65.84 | Standard Deviation 18.36 | mm |
| Change in the Sore Throat Intensity by 100 mm VAS | Angal S (Arm A) | Day 4 (Visit 2) | 2.99 | Standard Deviation 10.33 | mm |
| Change in the Sore Throat Intensity by 100 mm VAS | ANTI-ANGIN® FORMULA (Arm B) | Day 4 (Visit 2) | 5.06 | Standard Deviation 11.06 | mm |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Angal S (Arm A) | 114 | |
| Overall Study | STARTED | ANTI-ANGIN® FORMULA (Arm B) | 115 | |
| Overall Study | Per Protocol Population | Angal S (Arm A) | 112 | |
| Overall Study | Per Protocol Population | ANTI-ANGIN® FORMULA (Arm B) | 111 | |
| Overall Study | Safety Population | Angal S (Arm A) | 114 | |
| Overall Study | Safety Population | ANTI-ANGIN® FORMULA (Arm B) | 115 | |
| Overall Study | ITT Population | Angal S (Arm A) | 114 | |
| Overall Study | ITT Population | ANTI-ANGIN® FORMULA (Arm B) | 115 | |
| Overall Study | COMPLETED | Angal S (Arm A) | 114 | |
| Overall Study | COMPLETED | ANTI-ANGIN® FORMULA (Arm B) | 114 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | Angal S (Arm A) | 1 | 114 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | ANTI-ANGIN® FORMULA (Arm B) | 0 | 115 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Angal S (Arm A) | 1 | 114 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | ANTI-ANGIN® FORMULA (Arm B) | 1 | 115 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Angal S (Arm A) | 0 | 114 | 0 |
| other | Diarrhea | Gastrointestinal disorders | ANTI-ANGIN® FORMULA (Arm B) | 1 | 115 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Angal S (Arm A) | 1 | 114 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | ANTI-ANGIN® FORMULA (Arm B) | 0 | 115 | 0 |
| other | Gingival pain | Gastrointestinal disorders | Angal S (Arm A) | 1 | 114 | 1 |
| other | Gingival pain | Gastrointestinal disorders | ANTI-ANGIN® FORMULA (Arm B) | 0 | 115 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Angal S (Arm A) | 0 | 114 |
| Total, all-cause mortality | ANTI-ANGIN® FORMULA (Arm B) | 0 | 115 |
| Total, other adverse events | Angal S (Arm A) | 7 | 114 |
| Total, other adverse events | ANTI-ANGIN® FORMULA (Arm B) | 11 | 115 |
| Total, serious adverse events | Angal S (Arm A) | 0 | 114 |
| Total, serious adverse events | ANTI-ANGIN® FORMULA (Arm B) | 0 | 115 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Angal S (Arm A) vs ANTI-ANGIN® FORMULA (Arm B): Number of Participants Who Fully Recovered | Trial comparisons |
| Angal S (Arm A) vs ANTI-ANGIN® FORMULA (Arm B): deaths from any cause | Trial comparisons |
| Angal S (Arm A) vs ANTI-ANGIN® FORMULA (Arm B): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03095508
GET https://conductscience.org/api/trials/v1/NCT03095508/events?page=2