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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01533220
First received: February 9, 2012
Last updated: September 24, 2013
Last verified: September 2013

February 9, 2012
September 24, 2013
June 2013
October 2013   (final data collection date for primary outcome measure)
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

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.

The response rate is calculated using the following formula:

Response rate = (PFNIvi - PFNIvf) / PFNIvi

Considering:

  • PFNIvi: PFNI in the first visit;
  • PFNIvf: PFNI at the last visit;
Same as current
Complete list of historical versions of study NCT01533220 on ClinicalTrials.gov Archive Site
Safety will be evaluated by the Adverse events occurence [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Same as current
Not Provided
Not Provided
 
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
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

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Flu
  • Cold
  • Allergic Disorder of Respiratory System
  • Drug: naphazoline hydrocloride
    02 drops into each nostril, 04 times a day for 05 days
  • Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
    02 drops into each nostril each 12 hours for 05 days
  • Experimental: Test group

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

    02 drops in each nostril every 12 hours for 5 days

    Intervention: Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
  • Active Comparator: Comparator group

    Naphazoline Hydrocloride (0.5mg)

    02 drops in each nostril every 12 hours for 5 days

    Intervention: Drug: naphazoline hydrocloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01533220
NMPEMS1011
Yes
EMS
EMS
Not Provided
Principal Investigator: Marco César MD Santos, Jorge IPO - PR
EMS
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP