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A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.

NCT03439436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-10-18

No results posted yet for this study

Summary

An observer-blind, multi-centre, randomized, parallel-group study to compare the efficacy and safety of two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of nasal congestion caused by an acute upper respiratory tract infection in adults.

Conditions

  • Nasal Congestion

Interventions

DRUG

xylo+dex nasal spray (0.1 mg+5 mg/dose)

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

DRUG

Nasic

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Dmitry Lioznov, MD · The First St. Petersburg state medical University n.a. Acad. I. P. Pavlov

  • Tatiana E Morozova, MD · First Moscow State Medical University n. a. I. M. Sechenov

  • Vladimir Popov, MD · Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"

  • Zhanna M Sizova, MD · City Polyclinic #2

  • Konstantin A Zakharov, MD · "Scientific and Research centre Eco-safety" Limited Liability Company

  • Alison Hughes · R&D MedClin EMEA, J&J

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-05-02
Completion
2018-05-02

Countries

  • Russia

Study Locations

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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 NCT03439436 on ClinicalTrials.gov