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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257243

Enrollment

260

Registered

2010-12-09

Start date

2012-10-01

Completion date

2013-10-25

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

cough, symptoms, cold, flu

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

Interventions

DRUGSyrup of oxomemazine, guaifenesin and potassium iodate

5ml each 4 hours

DRUGSyrup of guaifenesin

5ml each 4 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction/improvement of cough symptoms	DAY 7	The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary

Measure	Time frame	Description
Tolerance	DAY 7	Adverse events will be collected and followed in order to evaluate safety and tolerability

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026