Actively Recruiting
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2024-08-02
177
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or treating physician, treatment with the researching product is indicated and may present clinical benefit
You will not qualify if you...
- Respiratory symptoms suspected to be bacterial with conditions like rhinosinusitis, lower respiratory tract disease, or acute otitis media
- Participation in another clinical trial involving investigational treatment within 4 weeks prior to study start
- Participation influenced by employment with research site, sponsor, or being an inmate
- Diseases affecting prognosis and preventing outpatient management such as end-stage cancer, kidney, heart, respiratory or liver failure, mental illness, or scheduled surgeries/hospital procedures
- Any disease or condition posing a risk or confusing safety and efficacy of the study drug
- Contraindications to the study drug for medical reasons
- Allergy or hypersensitivity to Ibuprofen, Loratadine, related products, or excipients
- Pregnant women, breastfeeding, or planning pregnancy during the study
- Significant gastrointestinal diseases like gastric ulcer, Crohn's disease, or Ulcerative Colitis
- Chronic liver failure Child-Pugh A, B, or C
- Acute renal failure with glomerular filtration rate below 30 ml/min/1.72 m2
- History of alcohol or drug abuse in the last year
- Symptoms suggestive of COVID-19 or contact with suspected/positive COVID-19 case in last 14 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
Research Team
J
Jorge A Gonzalez, PhD
CONTACT
Y
Yulia Romero-Antonio, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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