This trial is active, not recruiting.

Conditions flu, cold, allergic disorder of respiratory system
Treatments naphazoline hydrocloride, naphazoline hydrocloride + pheniramine maleate + panthenol
Phase phase 3
Sponsor EMS
Start date June 2013
End date October 2013
Trial size 212 participants
Trial identifier NCT01533220, NMPEMS1011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 5 days
naphazoline hydrocloride + pheniramine maleate + panthenol
02 drops into each nostril each 12 hours for 05 days
(Active Comparator)
Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 5 days
naphazoline hydrocloride
02 drops into each nostril, 04 times a day for 05 days

Primary Outcomes

Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
time frame: Day 5

Secondary Outcomes

Safety will be evaluated by the Adverse events occurence
time frame: Day 5

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

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
Principal investigator Marco César MD Santos, Jorge
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by EMS.