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

Sponsor

EMS (Industry)

Overall Status

Completed

CT.gov ID

NCT01257243

Collaborator

(none)

260

Enrollment

Location

Arms

12.8

Actual Duration (Months)

20.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cough	Drug: Syrup of oxomemazine, guaifenesin and potassium iodate Drug: Syrup of guaifenesin	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

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

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Sep 30, 2013

Actual Study Completion Date :

Oct 25, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DRUG 1 Syrup of oxomemazine, guaifenesin and potassium iodate	Drug: Syrup of oxomemazine, guaifenesin and potassium iodate 5ml each 4 hours
Active Comparator: DRUG 2 Syrup of guaifenesin	Drug: Syrup of guaifenesin 5ml each 4 hours

Arm

Intervention/Treatment

Experimental: DRUG 1

Syrup of oxomemazine, guaifenesin and potassium iodate

Drug: Syrup of oxomemazine, guaifenesin and potassium iodate

5ml each 4 hours

Active Comparator: DRUG 2

Syrup of guaifenesin

Drug: Syrup of guaifenesin

5ml each 4 hours

Outcome Measures

Primary Outcome Measures

Reduction/improvement of cough symptoms [DAY 7]
The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary Outcome Measures

Tolerance [DAY 7]
Adverse events will be collected and followed in order to evaluate safety and tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.