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

Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257243
• Other study ID #: OGPGEMS0110
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2012
• Est. completion date: October 25, 2013

Study information

• Verified date: April 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 25, 2013
• Est. primary completion date: September 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Syrup of oxomemazine, guaifenesin and potassium iodate
5ml each 4 hours
• Syrup of guaifenesin
5ml each 4 hours

Locations

Country	Name	City	State
Brazil	Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction/improvement of cough symptoms	The reduction of cough symptoms will be evaluated by comparative score index basal and final score	DAY 7
Secondary	Tolerance	Adverse events will be collected and followed in order to evaluate safety and tolerability	DAY 7