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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Flu; Cold; Allergic Disorder of Respiratory System

Intervention: naphazoline hydrocloride (Drug); Naphazoline hydrocloride + Pheniramine Maleate + Panthenol (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Marco César MD Santos, Jorge, Principal Investigator, Affiliation: IPO - PR

Summary

The common cold is a major cause of nasal obstruction and reaches children and adults twice 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 treatment. The study was designed to parallel distribution, with two equal groups, with one group will receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

Clinical Details

Official title: A Randomized, Double-blind, Prospective, Monocentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay

Secondary outcome: Safety will be evaluated by the Adverse events occurence

Detailed description: STUDY DESIGN

- randomized,double blind, prospective,monocentric, parallel group, intent to treat trial

- Experiment duration: 5 days

- 4 visits (days 0,1,3 and 5)

- Evaluation of symptoms reduction

- Adverse events evaluation

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients must be able to understand the study procedures, agree to participate and give written consent. 2. Patients aged over 12 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 48 hours; 5. Patients with good mental health; 6. Negative urine pregnancy test 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

Locations and Contacts

Instituto Paranaense de Otorrinolaringologia, Curitiba, Parana 80620010, Brazil
Additional Information

Starting date: June 2013
Last updated: September 24, 2013

Page last updated: August 23, 2015

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