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

ConditionCommon Cold
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Silanes S.A. de C.V.

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.

Eligibility criteria

Qualifiers

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 with the common cold with maximum of 3 days since presentation

Women of childbearing potential under a medically acceptable method of contraception

Disqualifiers

Patients in whom respiratory symptoms are suspected to be of bacterial origin and generate a clinical picture compatible with: Rhinosinusitis (muco-purulent discharge, headache or facial pain, etc.), lower respiratory tract disease (wheezing, crackles, productive cough, etc.), acute otitis media (otalgia, purulent discharge from the ear, auditory discomfort, etc.).

Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start

Patients in whom participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)

At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures

Trial design

Treatments tested in this trial

  • Ibuprofen + Loratadine fixed dose
  • Ibuprofen
  • Loratadine

Treatment groups

177 Participants
are divided into 3 treatment groups