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Trial record 26 of 32 for:    PANTHENOL

Efficacy and Safety of Pediatric Drugs in Nasal Congestion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601235
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
EMS

Brief Summary:
The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.

Condition or disease Intervention/treatment Phase
Nasal Congestion Drug: Naridrin Drug: Afrin Phase 3

Detailed Description:
Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naridrin
Naridrin: 2 drops in each nostril once daily as prescription
Drug: Naridrin
Naridrin® : 2 drops in each nostril once daily as prescription
Other Names:
  • Naphazoline Hydrochloride
  • Mepyramine Maleate
  • Dexpanthenol

Active Comparator: 0.05 % Oxymetazoline Hydrochloride
2 pumps in each nostril every 12 hours
Drug: Afrin
2 pumps in each nostril every 12 hours.
Other Name: oxymetazoline hydrochloride




Primary Outcome Measures :
  1. Relief of Nasal Congestion [ Time Frame: 2 days ]
    Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 days ]

    Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up.

    The evaluation of the heart frequency will also be a safety parameter.




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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
  • Signed Consent;
  • Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
  • Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
  • Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).

Exclusion Criteria:

  • Participation in clinical trial in the year prior to this study;
  • Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
  • Infectious bacterial-disease (clinically diagnosed);
  • Participants treated with antibiotic or possible antibiotic use due to another medical condition;
  • Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
  • Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
  • Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
  • Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
  • History of hyperthyroidism or hypertension;
  • History of hypersensitivity to the components of the study drugs;
  • History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
  • Exclusive mouth-breathers patients;
  • Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
  • History of alcohol and / or drug abuse 3 months prior to the study;
  • Smokers
  • Pregnancy or risk of pregnancy and lactating patients;
  • PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601235


Contacts
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Contact: Monalisa F.B. Oliveira, M.D. + 55 19 3887-9851 pesquisa.clinica@ems.com.br

Locations
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Brazil
Faculdade de Medicina do ABC Recruiting
Santo André, SP, Brazil
Principal Investigator: Neusa Wandalsen, MD         
Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02601235     History of Changes
Other Study ID Numbers: NMDEMS0214NA-III
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMS:
nasal congestion
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents