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

Information source: EMS
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cough

Intervention: Syrup of oxomemazine, guaifenesin and potassium iodate (Drug); Syrup of guaifenesin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Felipe Pinho, MD, Study Director, Affiliation: EMS

Overall contact:
Pesquisa Clínica, Phone: 551138879851, Email: pesquisa.clinica@ems.com.br

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Reduction/improvement of cough symptoms

Secondary outcome: Tolerance

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Pesquisa Clínica, Phone: 551138879851, Email: pesquisa.clinica@ems.com.br

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro, São Paulo 02189-000, Brazil; Recruiting
Flávio Sano, Principal Investigator
Additional Information

Starting date: February 2013
Last updated: February 26, 2013

Page last updated: November 27, 2014

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