Status:
RECRUITING
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Common Cold
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Ibupro...
Detailed Description
Researchers will compare the fixed-dose combination of Ibuprofen + Loratadine versus Ibuprofen versus Loratadine for the symptomatic treatment of the common cold. The adverse events related to the int...
Eligibility Criteria
Inclusion
- 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
- At the discretion of the Principal Investigator (PI) or treating physician, treatment with the researching product is indicated and may present clinical benefit
Exclusion
- 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
- History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of 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 study drugs, related products or excipients (Ibuprofen of Loratadine)
- Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
- Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, 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
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2025
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06531707
Start Date
May 20 2024
End Date
February 20 2025
Last Update
August 2 2024
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000