Trials / Suspended
SuspendedNCT02904304
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Ache Laboratorios Farmaceuticos S.A. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
Detailed description
The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen. The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect. The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart. The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Desloratadine+Phenylephrine+Ibuprofen | 01 tablet, orally, every 12 hours. |
| DRUG | Placebo | 01 tablet, orally, every 12 hours. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-07-01
- Completion
- 2021-09-01
- First posted
- 2016-09-16
- Last updated
- 2019-07-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02904304. Inclusion in this directory is not an endorsement.