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

Browse trials for

• Pharyngitis 252

Keywords

• Angal S
• ANTI-ANGIN FORMULA
• Sore Throat
• no less therapeutic efficacy

Pharyngitis

252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.

This study's enrollment of 229 is above the median of 144 across 209 interventional studies indexed under Pharyngitis.

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Study arms

• Experimental
  Angal S (Arm A)

  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

  Drug: Angal S, topical spray [Menthol]

• Active comparator
  ANTI-ANGIN® FORMULA (Arm B)

  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

  Drug: ANTI-ANGIN® FORMULA, topical metered spray

Interventions

• DrugAngal 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

• DrugANTI-ANGIN® FORMULA, topical metered spray

  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

Primary outcomes

1. 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.

   Time frame: 4 Days

Secondary outcomes

1. 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.

   Time frame: 4 days

2. 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.

   Time frame: 4 days

3. 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)

   Time frame: Group A: 4 days Group B: 5 days

4. 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.

   Time frame: 4 days

5. 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.

   Time frame: 5 Days

Baseline characteristics

Study documents

• Study protocol · Sep 29, 2016
• Statistical analysis plan · Feb 15, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No