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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Flu Cold Allergic Disorder of Respiratory System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test group

Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).

02 drops in each nostril every 12 hours for 3 days

Group Type EXPERIMENTAL

Naphazoline hydrocloride + Pheniramine Maleate + Panthenol

Intervention Type DRUG

02 drops into each nostril each 12 hours for 03 days

Comparator group

Naphazoline Hydrocloride (0.5mg)

02 drops in each nostril every 12 hours for 3 days

Group Type ACTIVE_COMPARATOR

naphazoline hydrocloride

Intervention Type DRUG

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

Interventions

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naphazoline hydrocloride

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

Intervention Type DRUG

Naphazoline hydrocloride + Pheniramine Maleate + Panthenol

02 drops into each nostril each 12 hours for 03 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must be able to understand the study procedures, agree to participate and give 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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No