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

EMS

Status and phase: Completed; Phase 3

Conditions: Cough

Treatments: Drug: Syrup of guaifenesin; Drug: Syrup of oxomemazine, guaifenesin and potassium iodate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257243

OGPGEMS0110

Details and patient eligibility

About

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.

Full 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

Enrollment: 260 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

DRUG 1

Experimental group

Description:

Syrup of oxomemazine, guaifenesin and potassium iodate

Treatment:

Drug: Syrup of oxomemazine, guaifenesin and potassium iodate

DRUG 2

Active Comparator group

Description:

Syrup of guaifenesin

Treatment:

Drug: Syrup of guaifenesin