Sore ThroatPhase 3NCT03095521

A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

A Phase 3 study testing Angal, lozenges [menthol], and ANTI-ANGIN® FORMULA 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, 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… 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, lozenges [menthol], and ANTI-ANGIN® FORMULA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 14 sitesRussia
Study dates: 22 Feb 2017to 7 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);

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: A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and 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.

Conditions: Sore Throat
Being tested: Angal, lozenges [menthol],, ANTI-ANGIN® FORMULA
Keywords: Angal, 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, 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.
ANTI-ANGIN® FORMULADrug
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.

Study groups in NCT03095521
Study group	Role	What they receive
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. Receives: Drug: Angal, lozenges [menthol],
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. Receives: Drug: ANTI-ANGIN® FORMULA

What is being measured

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

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
1. : insignificant symptom
2. : moderate symptom
3. : significant symptom fever
0 pts : <37.5 °С;
1. pts : 37.5 to <38.5 °С;
2. pts : 38.5 to <39.5 °С;
3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Measured: 4 days

Secondary outcomes (5)

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
Measured: day 4
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
1. : insignificant symptom
2. : moderate symptom
3. : significant symptom fever
0 pts : <37.5 °С;
1. pts : 37.5 to <38.5 °С;
2. pts : 38.5 to <39.5 °С;
3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.
Measured: 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
Measured: 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)
Measured: 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.
Measured: baseline, day 4

Timeline

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

22 Feb 20177 May 2017

First posted29 Mar 2017
Study start22 Feb 2017
Primary completion7 May 2017
Study completion7 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: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03095521
Sponsor's protocol ID: TE_004_ANG_LOZ
Status last verified: Dec 2018
First submitted: 21 Mar 2017
Last updated: 22 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 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Open, Randomized Clinical Study in Parallel Groups, for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol], 1 mg + 5 mg (Sandoz d.d., Slovenia), and 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.
ClinicalTrials.gov ID: NCT03095521
Acronym / sponsor ID: TE_004_ANG_LOZ
Conditions: Sore Throat
Keywords: Angal, ANTI-ANGIN® FORMULA, sore throat, no less therapeutic efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: SandozIndustry (pharma, biotech, devices)
Study start: 22 Feb 2017 (actual)
Primary completion: 7 May 2017 (actual)
Study completion: 7 May 2017 (actual)
First posted: 29 Mar 2017 (actual)
Results: Posted 22 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
Arm A	Experimental	Drug: Angal, lozenges [menthol],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	Drug: ANTI-ANGIN® FORMULAANTIANGIN ® 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.

Who may qualify

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

Key inclusion criteria (4 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);

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, lozenges [menthol],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.	Drug	Arm A
ANTI-ANGIN® FORMULA0,2 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.	Drug	Arm B

Primary outcome

Percentage of Participants Without Sore Throat According to TSS Score
Time frame: 4 days
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 1. : insignificant symptom 2. : moderate symptom 3. : significant symptom fever 0 pts : <37.5 °С; 1. pts : 37.5 to <38.5 °С; 2. pts : 38.5 to <39.5 °С; 3. pts : ≥ 39.5 °С. TSS total ranges are 0-15.

5 secondary outcomes

50% Reduction Tss SCORE
Time frame: day 4
Change From Baseline in TSS Total Score
Time frame: baseline and day 4
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)
Time frame: 5 days
Number of Participants Who Fully Recovered up to Day 5
Time frame: 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) .
Time frame: baseline, day 4

Results and safety

Results posted to the registry on 22 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	115	115
ANTIANGIN	113	111

Primary outcome: Percentage of Participants Without Sore Throat According to TSS Score

Time frame: 4 days. Number. Unit: percentage of participants

Measure	ANGAL n = 115	ANTIANGIN n = 112
sore throat TSS score 0	84.35	73.21
sore throat TSS score 1	13.91	17.86
sore throat TSS score 2	1.74	8.93
sore throat TSS score 3	0	0

ANGAL vs ANTIANGIN: p = 0.028, Fisher Exact

Population analysed: ITT, only patients with measurements were included (115 for Angal, and 112 for Antiangin)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ANGAL	0 of 115 (0%)	6 of 115 (5.2%)	0 of 115
ANTIANGIN	0 of 113 (0%)	12 of 113 (10.6%)	0 of 113

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 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, lozenges [menthol], and ANTI-ANGIN® FORMULA 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 4 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 22 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 22 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 Participants Without Sore Throat According to TSS Score (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 NCT03095521.

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 22 Mar 2019.