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Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Primary Purpose

Cough

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Syrup of oxomemazine, guaifenesin and potassium iodate

Syrup of guaifenesin

About this trial

This is an interventional treatment trial for Cough focused on measuring cough, symptoms, cold, flu

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
Cough score superior to 3.

Exclusion Criteria:

Pregnancy or risk of pregnancy.
Lactation.
Fever above 38º C.
Patients with bacterial infections of the upper respiratory tract.
Any pathology or past medical condition that can interfere with this protocol.

Sites / Locations

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DRUG 1

DRUG 2

Arm Description

Syrup of oxomemazine, guaifenesin and potassium iodate

Syrup of guaifenesin

Outcomes

Primary Outcome Measures

Reduction/improvement of cough symptoms

The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary Outcome Measures

Tolerance

Adverse events will be collected and followed in order to evaluate safety and tolerability

Full Information

NCT ID

NCT01257243

First Posted

December 8, 2010

Last Updated

April 15, 2019

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01257243

Brief Title

Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

Official Title

Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2012 (Actual)

Primary Completion Date

September 30, 2013 (Actual)

Study Completion Date

October 25, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed Description

STUDY DESIGN Open-label, superiority, prospective, parallel group, intent to treat trial Experiment duration: 7 days 3 visits (days 1, 2 and 7) Reduction cough symptoms Adverse events evaluation

6. Conditions and Keywords

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

Cough

Keywords

cough, symptoms, cold, flu

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DRUG 1

Arm Type

Experimental

Arm Description

Syrup of oxomemazine, guaifenesin and potassium iodate

Arm Title

DRUG 2

Arm Type

Active Comparator

Arm Description

Syrup of guaifenesin

Intervention Type

Drug

Intervention Name(s)

Syrup of oxomemazine, guaifenesin and potassium iodate

Intervention Description

5ml each 4 hours

Intervention Type

Drug

Intervention Name(s)

Syrup of guaifenesin

Intervention Description

5ml each 4 hours

Primary Outcome Measure Information:

Title

Reduction/improvement of cough symptoms

Description

The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Time Frame

DAY 7

Secondary Outcome Measure Information:

Title

Tolerance

Description

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time Frame

DAY 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day. Cough score superior to 3. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation. Fever above 38º C. Patients with bacterial infections of the upper respiratory tract. Any pathology or past medical condition that can interfere with this protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Pinho, MD

Organizational Affiliation

EMS

Official's Role

Study Director

Facility Information:

Facility Name

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

City

São Paulo

ZIP/Postal Code

02189-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

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