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

NCT01533220 | Completed Phase 3 DMC

• 1 other identifier: NMPEMS1011
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Flu; Cold; Allergic Disorder of Respiratory System

Keywords

nasal and nasopharyngeal congestion

Outcome Measures

Primary Outcomes (1)

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

  The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit.

  3 days

Secondary Outcomes (1)

• Safety will be evaluated by the Adverse events occurence

  3 days

Study Arms (2)

Test group

EXPERIMENTAL

Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days

Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol

Comparator group

ACTIVE COMPARATOR

Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days

Drug: naphazoline hydrocloride

Interventions

naphazoline hydrocloride DRUG

02 drops into each nostril, 04 times a day for 03 days

Comparator group

Naphazoline hydrocloride + Pheniramine Maleate + Panthenol DRUG

02 drops into each nostril each 12 hours for 03 days

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to understand the study procedures, agree to participate and give written consent.
• Patients aged over 18 years of both sexes;
• Patients with clinical signs of flu and colds or other upper respiratory allergies;
• Patients with early signs and symptoms with time of evolution not more than 72 hours.

You may not qualify if:

• Patients treated with antibiotics
• Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
• Use of decongestants or anti-histaminic (intranasal or systemic);
• Presence of any disease or anatomical abnormality that may difficult the data analysis ;
• Uncontrolled hypertension;
• Presence of respiratory symptoms for more than 14 days;
• History of abuse of drugs and alcohol;
• Presence of other concomitant pulmonary diseases;
• Hypersensitivity to any compound of investigational product

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Influenza, Human; Common Cold

Interventions

Pheniramine; dexpanthenol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 15, 2012
• Study Start: January 1, 2013
• Primary Completion: August 31, 2013
• Study Completion: April 30, 2014
• Last Updated: January 25, 2019

Record last verified: 2019-01