Phase
Condition
Common Cold
Acute Rhinitis
Treatment
Loratadine
Ibuprofen + Loratadine fixed dose
Ibuprofen
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andquestioning (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
At the discretion of the Principal Investigator (PI) or treating physician,treatment with the researching product is indicated and may present clinical benefit
Exclusion
Exclusion Criteria:
Patients in whom respiratory symptoms are suspected to be of bacterial origin andgenerate a clinical picture compatible with: Rhinosinusitis (muco-purulentdischarge, headache or facial pain, etc.), lower respiratory tract disease (wheezing, crackles, productive cough, etc.), acute otitis media (otalgia, purulentdischarge from the ear, auditory discomfort, etc.).
Patients participating in another clinical trial involving an investigationaltreatment or participation in one within 4 weeks prior to study start
Patients in whom participation in the study may be influenced (employmentrelationship with the research site or sponsor, inmates, etc.)
At medical discretion, a disease that affects prognosis and prevents outpatientmanagement, for example, but not limited to: end-stage cancer, kidney, heart,respiratory or liver failure, mental illness or with scheduled surgical or hospitalprocedures
History/presence of any disease or condition that, in the opinion of theInvestigator, could pose a risk for the patient or confusing the efficacy and safetyof the investigational product
Patients in whom the study drug is contraindicated for medical reasons
Patients with allergy or hypersensitivity to the active substance of the studydrugs, related products or excipients (Ibuprofen of Loratadine)
Pregnant women, women breastfeeding or planning a pregnancy during the conductingthe study
Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn'sdisease, Ulcerative Colitis, etc.)
History of chronic liver failure Child-Pugh A, B, and/or C
History of acute renal failure (glomerular filtration rate <30 ml/min/1.72 m2)
Patients with a history of alcohol or drug abuse in the last year
Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea)and/or contact in the last 14 days with a suspected or positive patient for COVID-19
Study Design
Study Description
Connect with a study center
Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000
MexicoActive - Recruiting
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