Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

Recruiting Phase 3 Interventional Study
Common Cold
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
177 (estimated)
Sponsor
Laboratorios Silanes S.A. de C.V. · Industry
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About This Trial

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Agree to participate in the study and give written informed consent * At least 6 points on the Jackson scale according to physical examination and questioning (sneezing, runny nose, nasal obstruction, sore throat, cough, headache, malaise, and chills). * Symptoms associated wi…
Contacts

Jorge A Gonzalez, PhD

5254883785

jogonzalez@silanes.com.mx

CONTACT

Yulia Romero-Antonio, B.S.

5254883785

yromero@silanes.com.mx

CONTACT