Comparing Ibuprofen and Loratadine combinations for treating the common cold

Efficacy and Safety of Ibuprofen/Loratadine Fixed-dose Combination Versus the Fixed-dose Administration of Monotherapy as Symptomatic Treatment for Patients With the Common Cold

This study is testing if a combination of Ibuprofen and Loratadine can help people with cold symptoms feel better than taking each medicine alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratorios Silanes S.A. de C.V. (industry)
• Locations: 1 site (Mexico City)
• Trial ID: NCT06531707 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of a fixed-dose combination of Ibuprofen and Loratadine compared to each drug alone for treating symptoms of the common cold. Participants will be randomized into three groups and monitored over a week, with surveys assessing their symptoms. The study aims to determine if the combination therapy provides better relief than monotherapy. Adverse events will also be recorded to ensure safety during the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals experiencing symptoms of the common cold for no more than three days and scoring at least six points on the Jackson scale.

Not a fit: Patients with respiratory symptoms suspected to be of bacterial origin or those with more severe respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from the common cold.

How similar studies have performed: Previous studies have shown varying results with similar combinations, but this specific approach is relatively novel.

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

Where this trial is running

Mexico City

• Laboratorio Silanes, S.A. de C.V. — Mexico City, Mexico (RECRUITING)

Study contacts

• Principal investigator: Ana Luara Flores-Barranco, MD — Oaxaca Site Management Organization
• Study coordinator: Jorge A Gonzalez, PhD

Conditions: Common Cold, Flu, Ibuprofen, Loratadine