Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
Information source: EMS
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Not yet recruiting
Sponsored by: EMS Official(s) and/or principal investigator(s):
Felipe Pinho, MD, Study Director, Affiliation: EMS
Overall contact:
Priscila Russo, M.Sc., Phone: 551138879851
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 38ยบ 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
Priscila Russo, M.Sc., Phone: 551138879851 Additional Information
Starting date: March 2011
Last updated: February 1, 2011
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