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Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat

NCT03282045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2021-03-16

No results posted yet for this study

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).

Conditions

  • Sore Throat

Interventions

DRUG

Lysobact Complete Sprey

Inhaling spray

DRUG

Tantum Verde® Spray

Inhaling spray

DRUG

Pharyngal® Oromucosal Spray

Inhaling spray

DRUG

Placebo

Inhaling spray

Sponsors & Collaborators

  • MonitorCRO

    collaborator INDUSTRY

  • Bosnalijek D.D

    lead INDUSTRY

Principal Investigators

  • OZGUN ENVER, MD · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-05-24
Completion
2018-05-24

Countries

  • Bosnia and Herzegovina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282045 on ClinicalTrials.gov