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

Launched by LABORATORIOS SILANES S.A. DE C.V. · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a combination of two medications—Ibuprofen and Loratadine—compared to each medication taken alone for treating the common cold. The goal is to find out if the combination works better to relieve symptoms such as sneezing, runny nose, sore throat, and headaches. The trial is currently looking for participants aged 65 to 74 who are experiencing cold symptoms that started within the last three days and score at least 6 points on a specific symptom scale.

To participate, individuals must agree to be part of the study and provide written consent. They should not have any severe respiratory illnesses or other medical conditions that could complicate the study. Participants will receive either the combination treatment, Ibuprofen alone, or Loratadine alone, and they will be monitored for any effects or benefits from the treatment. It’s important to note that pregnant or breastfeeding women, and those with certain health conditions, will not be eligible for this trial. If you or someone you know fits the criteria and is interested, this could be an opportunity to help researchers learn more about treating common cold symptoms.

Gender

ALL

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 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 Criteria:
• • 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