CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 229 enrolled
Drug / intervention
Angal S, topical spray [Menthol] +1 moredrug
Likely dose
Angal S 0.5 mg + 2 mg (menthol), 3–5 presses 6–10 times daily for maximum 4 days; ANTI-ANGIN® FORMULA 0.12 mg + 0.24 mg, 1–2 presses up to 6 times daily for maximum 5 daysAI-extracted
Key inclusion· 5
  • ✓Age 18 to 45 years, male or female
  • ✓Diagnosed uncomplicated acute infectious and inflammatory pharyngeal disease with sore throat
  • ✓Symptom onset within 48 hours prior to study entry
  • ✓Baseline Tonsillopharyngitis Severity Score (TSS) ≥5
Key exclusion· 5
  • ✕Analgesic use within 12 hours prior to study start or inability to discontinue during study
  • ✕Antibiotic use within 48 hours prior to study start or inability to discontinue during study
  • ✕Local pharyngeal therapy (sprays, rinses, lozenges) within 12 hours before study start or inability to discontinue (except study medication)
  • ✕Systemic or inhaled corticosteroid use within 1 month prior to study start or planned use during study (excluding topical skin preparations)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095508
NCT03095508Phase 3Completed
CompareCT.gov

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

Sandoz·interventional·Posted Mar 29, 2017·Updated Mar 21, 2019

In Brief

A Phase 3 clinical trial evaluating Angal S, topical spray [Menthol] and ANTI-ANGIN® FORMULA, topical metered spray for Sore Throat. Completed, enrolled 229 participants across 14 sites.

Detailed 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 and inflammatory diseases of the pharynx, accompanied by a sore throat.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSore Throat
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartFeb 22, 2017
Primary CompletionMay 8, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.3 years ago

Interventions

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