NCT06531707 Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
| NCT ID | NCT06531707 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Laboratorios Silanes S.A. de C.V. |
| Condition | Common Cold |
| Study Type | INTERVENTIONAL |
| Enrollment | 177 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2025-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 177 participants in total. It began in 2024-05-20 with a primary completion date of 2025-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
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
Contact & Investigator
Ana Luara Flores-Barranco, MD
PRINCIPAL INVESTIGATOR
Oaxaca Site Management Organization
Frequently Asked Questions
Who can join the NCT06531707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Common Cold. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06531707 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 177 participants.
Is NCT06531707 currently recruiting?
Yes, NCT06531707 is actively recruiting participants. Contact the research team at jogonzalez@silanes.com.mx for enrollment information.
Where is the NCT06531707 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06531707 clinical trial?
NCT06531707 is sponsored by Laboratorios Silanes S.A. de C.V.. The principal investigator is Ana Luara Flores-Barranco, MD at Oaxaca Site Management Organization. The trial plans to enroll 177 participants.