Back to resultsEfficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
Primary Purpose
Common Cold
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Irlanda-2-Association
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
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.
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.
Sites / Locations
- Allergisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Irlanda-2-Association
Placebo
Arm Description
Take 10 mL every 12 hours (2x/day), oral route.
Take 10 mL every 12 hours (2x/day), oral route.
Outcomes
Primary Outcome Measures
Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02656914
Brief Title
Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
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
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Withdrawn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
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-2-Association
Arm Type
Experimental
Arm Description
Take 10 mL every 12 hours (2x/day), oral route.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take 10 mL every 12 hours (2x/day), oral route.
Intervention Type
Drug
Intervention Name(s)
Irlanda-2-Association
Intervention Description
Take 10 mL every 12 hours (2x/day), oral route.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Take 10 mL every 12 hours (2x/day), oral route.
Primary Outcome Measure Information:
Title
Determine efficacy of Irlanda-2-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
18 Years
Maximum Age & Unit of Time
60 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.
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.
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-2 Association on the Treatment of Common Cold
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