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Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

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: NCT02656888
Recruitment Status : Not yet recruiting
First Posted : January 15, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
EMS

Brief Summary:
The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Condition or disease Intervention/treatment Phase
Common Cold Drug: Irlanda-1-Association Drug: Placebo Phase 3

Detailed Description:
Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind study
Primary Purpose: Treatment
Official Title: Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Experimental: Irlanda-1-Association
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
Drug: Irlanda-1-Association
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
Other Name: EMS association

Placebo Comparator: Placebo
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
Drug: Placebo
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.




Primary Outcome Measures :
  1. Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Safety will be evaluated by the adverse events occurrences [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
  • Signed Consent of the patient;
  • Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE

Exclusion Criteria:

  • Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
  • Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
  • Patients with history of hypersensitivity to any of the formula compounds;
  • Participation in clinical trial in the year prior to this study;
  • Patients with vaccine reaction;
  • Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
  • Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
  • Patients with diabetes mellitus type I and II;
  • Pregnancy or risk of pregnancy and lactating patients;
  • Patients who were in use of drugs that can interfere with flu symptoms evaluation.

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): NCT02656888


Contacts
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Contact: Monalisa FB Oliveira, M.D. +551938879851 pesquisa.clinica@ems.com.br

Locations
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Brazil
Allergisa
Campinas, São Paulo, Brazil
Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02656888     History of Changes
Other Study ID Numbers: EMS0615
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases