drugset / Trial / NCT03282045
Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
RandomizedParallel-groupSingle-blindTreatment
Summary
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Timeline
- Start
- 2016-10
- Primary completion
- 2018-05-24
- Completion
- 2018-05-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorhexidine | Small molecule | 0.28 mg | Other |
| Comparator | Lidocaine | Other / unclassified | 0.07 mg | Other |
| Comparator | Lidocaine | Other / unclassified | 0.1 mg | Other |
| Subject | Lysozyme | Unknown | 4 mg | Other |
| Comparator | Tantum Verde® Spray | Unknown | — | Other |
| Subject | cetylpyridine | Unknown | 0.3 mg | Other |