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Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold

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: NCT02656914
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

Condition or disease Intervention/treatment Phase
Common Cold Drug: Irlanda-2-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-2 Association on the Treatment of Common Cold
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-2-Association
Take 10 mL every 12 hours (2x/day), oral route.
Drug: Irlanda-2-Association
Take 10 mL every 12 hours (2x/day), oral route.

Placebo Comparator: Placebo
Take 10 mL every 12 hours (2x/day), oral route.
Drug: Placebo
Take 10 mL every 12 hours (2x/day), oral route.




Primary Outcome Measures :
  1. Determine efficacy of Irlanda-2-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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Exclusion Criteria:

  • Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study;
  • Patients with any laboratory finding or image finding that, in the investigator 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 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): NCT02656914


Contacts
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Contact: Monalisa F.B. 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: NCT02656914     History of Changes
Other Study ID Numbers: EMS1115
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