Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal

Last updated: January 24, 2019
Sponsor: EMS
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Influenza

Allergy

Treatment

N/A

Clinical Study ID

NCT01533220
NMPEMS1011
  • Ages > 18
  • All Genders

Study Summary

The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.

The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be able to understand the study procedures, agree to participate andgive written consent.

  2. Patients aged over 18 years of both sexes;

  3. Patients with clinical signs of flu and colds or other upper respiratory allergies;

  4. Patients with early signs and symptoms with time of evolution not more than 72 hours.

Exclusion

Exclusion Criteria:

  1. Patients treated with antibiotics

  2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);

  3. Use of intranasal cromalin the week before inclusion;

  4. Use of decongestants or anti-histaminic (intranasal or systemic);

  5. Presence of any disease or anatomical abnormality that may difficult the data analysis ;

  6. Uncontrolled hypertension;

  7. Presence of respiratory symptoms for more than 14 days;

  8. History of abuse of drugs and alcohol;

  9. Presence of other concomitant pulmonary diseases;

  10. Hypersensitivity to any compound of investigational product

Study Design

Total Participants: 132
Study Start date:
January 01, 2013
Estimated Completion Date:
April 30, 2014

Study Description

STUDY DESIGN

  • randomized,double blind, prospective, multicentric, parallel group, intent to treat trial

  • Experiment duration: 3 days

  • 2 visits (days 0 and 2)

  • Evaluation of symptoms reduction

  • Adverse events evaluation

Connect with a study center

  • Instituto Paranaense de Otorrinolaringologia

    Curitiba, Parana 80620010
    Brazil

    Site Not Available

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