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

Primary Purpose

Common Cold

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Irlanda-1-Association
Placebo
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allergisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Irlanda-1-Association

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.

Secondary Outcome Measures

Safety will be evaluated by the adverse events occurrences

Full Information

First Posted
January 12, 2016
Last Updated
October 14, 2019
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT02656888
Brief Title
Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.
Detailed Description
Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind study
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irlanda-1-Association
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Irlanda-1-Association
Other Intervention Name(s)
EMS association
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Allergisa
City
Campinas
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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