drugset / Trial / NCT01938144
Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.
Timeline
- Start
- 2016-04
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 500 mg | — |
| Subject | Chlorpheniramine | Unknown | 4 mg | Oral |
| Subject | Ibuprofen | Small molecule | 200 mg | Oral |
| Subject | Phenylephrine | Small molecule | 10 mg | Oral |