Efficacy and Safety of Irlanda-2 Association on the Treat... | NCT02656914

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

NCT02656914

Sponsor

EMS

Status

Withdrawn

Last Update Posted

Oct 16, 2019Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Common Cold

Interventions

Irlanda-2-Association
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Jun 2019Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jan 12, 2016

First Submission Date that Met QC Criteria

Jan 13, 2016

First Posted Date

Jan 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2019

Last Update Posted Date

Oct 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Irlanda-2-Association	Experimental	Take 10 mL every 12 hours (2x/day), oral route.	Drug: Irlanda-2-Association
Placebo	Placebo Comparator	Take 10 mL every 12 hours (2x/day), oral route.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irlanda-2-Association	Drug	Take 10 mL every 12 hours (2x/day), oral route.	Irlanda-2-Association

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.		7 days

Secondary Outcomes

Measure	Description	Time Frame
Safety will be evaluated by the adverse events occurrences		7 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Allergisa		Campinas	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003139	Common Cold

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided