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

NCT ID: NCT01257243

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-01
• Study Completion Date: 2013-10-25

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

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DRUG 1

Syrup of oxomemazine, guaifenesin and potassium iodate

Group Type: EXPERIMENTAL

Syrup of oxomemazine, guaifenesin and potassium iodate

Intervention Type: DRUG

5ml each 4 hours

DRUG 2

Syrup of guaifenesin

Group Type: ACTIVE_COMPARATOR

Syrup of guaifenesin

Intervention Type: DRUG

5ml each 4 hours

Interventions

Syrup of oxomemazine, guaifenesin and potassium iodate

5ml each 4 hours

Intervention Type: DRUG

Syrup of guaifenesin

5ml each 4 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.

2. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.

3. Cough score superior to 3.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.

2. Lactation.

3. Fever above 38º C.

4. Patients with bacterial infections of the upper respiratory tract.

5. Any pathology or past medical condition that can interfere with this protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felipe Pinho, MD

Role: STUDY_DIRECTOR

EMS

Locations

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

OGPGEMS0110

Identifier Type: -

Identifier Source: org_study_id