Trial Outcomes & Findings for 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 (NCT NCT03095521)

Last Updated: 2019-03-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

228 participants

Primary outcome timeframe

4 days

Results posted on

2019-03-22

Participant Flow

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.

228 patients in total were included

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	115	113
Overall Study Intent to Treat Population ITT	115	113
Overall Study Per Protocol Population PP	113	107
Overall Study Safety Population	115	113
Overall Study COMPLETED	115	111
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

ITT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANGAL n=115 Participants 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.	ANTIANGIN n=113 Participants 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.	Total n=228 Participants Total of all reporting groups
Age, Continuous	30.44 years n=5 Participants • ITT	30.02 years n=7 Participants • ITT	30.23 years n=5 Participants • ITT
Sex: Female, Male Female	73 Participants n=5 Participants • ITT	67 Participants n=7 Participants • ITT	140 Participants n=5 Participants • ITT
Sex: Female, Male Male	42 Participants n=5 Participants • ITT	46 Participants n=7 Participants • ITT	88 Participants n=5 Participants • ITT
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants	113 Participants n=7 Participants	228 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

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

Outcome measures

Outcome measures
Measure	ANGAL n=115 Participants 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.	ANTIANGIN n=112 Participants 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.
Percentage of Participants Without Sore Throat According to TSS Score sore throat TSS score 0	84.35 percentage of participants	73.21 percentage of participants
Percentage of Participants Without Sore Throat According to TSS Score sore throat TSS score 1	13.91 percentage of participants	17.86 percentage of participants
Percentage of Participants Without Sore Throat According to TSS Score sore throat TSS score 2	1.74 percentage of participants	8.93 percentage of participants
Percentage of Participants Without Sore Throat According to TSS Score sore throat TSS score 3	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: day 4

Population: PP set was considered for the analysis, however only the number of patients with complete data at visit 2 were considered for the analysis

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

Outcome measures

Outcome measures
Measure	ANGAL n=110 Participants 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.	ANTIANGIN n=105 Participants 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.
50% Reduction Tss SCORE	97.35 percentage of participants Interval 92.44 to 99.45	98.13 percentage of participants Interval 93.41 to 99.77

SECONDARY outcome

Timeframe: baseline and day 4

Population: PP

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.

Outcome measures

Outcome measures
Measure	ANGAL n=113 Participants 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.	ANTIANGIN n=107 Participants 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.
Change From Baseline in TSS Total Score baseline	6.88 unit on a scale Interval 6.63 to 7.14	7.03 unit on a scale Interval 6.75 to 7.3
Change From Baseline in TSS Total Score day 4	0.45 unit on a scale Interval 0.31 to 0.6	0.83 unit on a scale Interval 0.57 to 1.08

SECONDARY outcome

Timeframe: 5 days

Population: PP

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

Outcome measures

Outcome measures
Measure	ANGAL n=111 Participants 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.	ANTIANGIN n=102 Participants 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.
Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)	3.75 days Standard Error 0.049	3.93 days Standard Error 0.059

SECONDARY outcome

Timeframe: 4 days for Angal, 5 days for AntiAngin

Population: PP

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)

Outcome measures

Outcome measures
Measure	ANGAL n=113 Participants 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.	ANTIANGIN n=107 Participants 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.
Number of Participants Who Fully Recovered up to Day 5	102 participants	104 participants

SECONDARY outcome

Timeframe: baseline, day 4

Population: PP, participants with measure

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.

Outcome measures

Outcome measures
Measure	ANGAL n=113 Participants 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.	ANTIANGIN n=107 Participants 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.
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . Baseline	66.38 millimeters Standard Deviation 17.60	66.99 millimeters Standard Deviation 18.03
Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) . day 4	2.35 millimeters Standard Deviation 7.96	4.67 millimeters Standard Deviation 10.67

Adverse Events

ANGAL

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

ANTIANGIN

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ANGAL n=115 participants at risk 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.	ANTIANGIN n=113 participants at risk 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.
Cardiac disorders Sinus Tachicardia	0.87% 1/115 • Number of events 1 • 5 days	0.00% 0/113 • 5 days
Gastrointestinal disorders diarrhea	0.00% 0/115 • 5 days	1.8% 2/113 • Number of events 2 • 5 days
Gastrointestinal disorders dry mouth	0.87% 1/115 • Number of events 1 • 5 days	1.8% 2/113 • Number of events 2 • 5 days
Gastrointestinal disorders dyspepsia	0.87% 1/115 • Number of events 1 • 5 days	0.00% 0/113 • 5 days
Gastrointestinal disorders epigastric discomfort	0.00% 0/115 • 5 days	0.88% 1/113 • Number of events 2 • 5 days
Gastrointestinal disorders hypoesthesia oral	0.00% 0/115 • 5 days	0.88% 1/113 • Number of events 2 • 5 days
General disorders pyrexia	0.00% 0/115 • 5 days	0.88% 1/113 • Number of events 1 • 5 days
Injury, poisoning and procedural complications ligament sprain	0.87% 1/115 • Number of events 1 • 5 days	0.00% 0/113 • 5 days
Investigations red blood cell analysis abnormal	0.87% 1/115 • Number of events 1 • 5 days	0.00% 0/113 • 5 days
Nervous system disorders dysgeusia	0.00% 0/115 • 5 days	0.88% 1/113 • Number of events 1 • 5 days
Nervous system disorders headache	0.87% 1/115 • Number of events 1 • 5 days	0.00% 0/113 • 5 days
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/115 • 5 days	1.8% 2/113 • Number of events 2 • 5 days
Respiratory, thoracic and mediastinal disorders pharyngeal hypoesthesia	0.00% 0/115 • 5 days	0.88% 1/113 • Number of events 1 • 5 days
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	0.87% 1/115 • Number of events 1 • 5 days	0.88% 1/113 • Number of events 1 • 5 days

Additional Information

Study Director

Sandoz

Phone: +41613241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER