Sore ThroatPhase 3NCT03095508

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

A Phase 3 study testing Angal S, topical spray [Menthol] and ANTI-ANGIN® FORMULA, topical metered spray in people with Sore Throat, run by Sandoz at 14 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Sore Throat
What is being tested?: Angal S, topical spray [Menthol] and ANTI-ANGIN® FORMULA, topical metered spray
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 14 sitesRussia
Study dates: 22 Feb 2017to 8 May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Voluntarily signed informed consent for participation in this clinical study;
18 to 45 years old inclusive, male and female;
Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);
Body temperature 37,5 C (axillary).

Who cannot join

Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before study start or/and inability to cancel them, besides study medications;
Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means);
Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr).

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Russia14 sites

Sandoz Investigational Site
Arkhangelsk, 163000
Sandoz Investigational Site
Moscow, 105018
Sandoz Investigational Site
Moscow, 115280
Sandoz Investigational Site
Moscow, 119192
Sandoz Investigational Site
Moscow, 127015
Sandoz Investigational Site
Moscow, 135215
Sandoz Investigational Site
Saint Petersburg, 188643
Sandoz Investigational Site
Saint Petersburg, 191036
Sandoz Investigational Site
Saint Petersburg, 196143
Sandoz Investigational Site
Saint Petersburg, 197706
Sandoz Investigational Site
Saint Petersburg, 198207
Sandoz Investigational Site
Saint Petersburg, 199178
Sandoz Investigational Site
Saint Petersburg, 199226
Sandoz Investigational Site
Stavropol, 355000

Other trials in Russia

About this study

Official title: Prospective, Multicenter, Open, Randomized, Parallel, Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray [Menthol], 0,5 mg + 2 mg / 1 ml (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Topical Metered Spray, 0,12 mg + 0,24 mg / Dose (OOO "Valeant", Russia) in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Conditions: Sore Throat
Being tested: Angal S, topical spray [Menthol], ANTI-ANGIN® FORMULA, topical metered spray
Keywords: Angal S, ANTI-ANGIN FORMULA, Sore Throat, no less therapeutic efficacy
Medical subject headings: Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
ANTI-ANGIN® FORMULA, topical metered sprayDrug
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

Study groups in NCT03095508
Study group	Role	What they receive
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 Receives: Drug: Angal S, topical spray [Menthol]
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 Receives: Drug: ANTI-ANGIN® FORMULA, topical metered spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 Days

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 5 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 20178 May 2017

First posted29 Mar 2017
Study start22 Feb 2017
Primary completion8 May 2017
Study completion8 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sore ThroatStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03095508
Sponsor's protocol ID: TE_003_ANG_LSP
Status last verified: Dec 2018
First submitted: 24 Mar 2017
Last updated: 21 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Open, Randomized, Parallel, Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray [Menthol], 0,5 mg + 2 mg / 1 ml (Sandoz d.d., Slovenia), and ANTI-ANGIN® FORMULA, Topical Metered Spray, 0,12 mg + 0,24 mg / Dose (OOO "Valeant", Russia) in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
ClinicalTrials.gov ID: NCT03095508
Acronym / sponsor ID: TE_003_ANG_LSP
Conditions: Sore Throat
Keywords: Angal S, ANTI-ANGIN FORMULA, Sore Throat, no less therapeutic efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: SandozIndustry (pharma, biotech, devices)
Study start: 22 Feb 2017 (actual)
Primary completion: 8 May 2017 (actual)
Study completion: 8 May 2017 (actual)
First posted: 29 Mar 2017 (actual)
Results: Posted 21 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Angal S (Arm A)	Experimental	Drug: Angal S, topical spray [Menthol]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	Drug: ANTI-ANGIN® FORMULA, topical metered sprayPatients 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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Voluntarily signed informed consent for participation in this clinical study;
18 to 45 years old inclusive, male and female;
Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5 (total score);
Body temperature 37,5 C (axillary).

Key exclusion criteria (5 listed)

Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before study start or/and inability to cancel them, besides study medications;
Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means);
Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased ESR 30 mm/hr).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	Angal S (Arm A)
ANTI-ANGIN® FORMULA, topical metered spray0,12 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	Drug	ANTI-ANGIN® FORMULA (Arm B)

Primary outcome

Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)
Time frame: 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.

5 secondary outcomes

Percentage of Participants With a ≥50% TSS Total Score Reduction
Time frame: 4 days
Change From Baseline in TSS Total Score
Time frame: 4 days
Number of Participants Who Fully Recovered
Time frame: Group A: 4 days Group B: 5 days
Change in the Sore Throat Intensity by 100 mm VAS
Time frame: 4 days
Period of Time Required for Disappearance of the Disease Symptoms
Time frame: 5 Days

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Angal S (Arm A)	114	114
ANTI-ANGIN® FORMULA (Arm B)	115	114

Primary outcome: Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)

Time frame: 4 Days. Number. Unit: Percentage of Participants

Measure	Angal S (Arm A) n = 114	ANTI-ANGIN® FORMULA (Arm B) n = 115
Score 0 (no sore throat)	89.47	75.65
Score 1	7.02	19.13
Score 2	2.63	4.35
Score 3	0.88	0.87

Angal S (Arm A) vs ANTI-ANGIN® FORMULA (Arm B): Risk Difference (RD): 0.14 (95% CI 0.03 to 0.24), p = 0.00001, Fisher Exact

Population analysed: ITT Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing informed consent (Day 1) until completion of the trial (Day 7).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Angal S (Arm A)	0 of 114 (0%)	7 of 114 (6.1%)	0 of 114
ANTI-ANGIN® FORMULA (Arm B)	0 of 115 (0%)	11 of 115 (9.6%)	0 of 115

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandoz study director

Sandoz

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Angal S, topical spray [Menthol] and ANTI-ANGIN® FORMULA, topical metered spray in people with Sore Throat, run by Sandoz at 14 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS) (time frame: 4 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03095508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.