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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

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 23, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms. [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Determine the superiority of association (Guaifenesin and Loratadine and Ibuprofen) in the treatment of flu symptoms, through the questionnaire outcomes sinonasal - SNOT 22, compared to guaifenesin, ibuprofen and loratadine take taken separately. [ Time Frame: 7 days ]
Change History Complete list of historical versions of study NCT02656914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Safety will be evaluated by the adverse events occurrences [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold
Detailed Description Double blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blind study
Primary Purpose: Treatment
Condition  ICMJE Common Cold
Intervention  ICMJE
  • Drug: Irlanda-2-Association
    Take 10 mL every 12 hours (2x/day), oral route.
  • Drug: Placebo
    Take 10 mL every 12 hours (2x/day), oral route.
Study Arms  ICMJE
  • Experimental: Irlanda-2-Association
    Take 10 mL every 12 hours (2x/day), oral route.
    Intervention: Drug: Irlanda-2-Association
  • Placebo Comparator: Placebo
    Take 10 mL every 12 hours (2x/day), oral route.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2018)
530
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
224
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monalisa F.B. Oliveira, M.D. +551938879851 pesquisa.clinica@ems.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656914
Other Study ID Numbers  ICMJE EMS1115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EMS
Verification Date January 2019

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