Clinical trial NCT06531707: Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Common Cold
Keywords: Common Cold
Flu
Ibuprofen
Loratadine
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 interventions will be registered during follow up.

In the event that the symptoms worsen or the patient's clinical condition warrants the use of any additional medication, the principal investigator or designated physician will be in charge of prescribing it according to the individual clinical condition and the physical examination, this will be recorded as "Concomitant medication".

Participants will:

* Be randomized into one of the 3 intervention groups (A,B,C)
* Visit the clinic at day 0 (day of enrollment) and at day 7
* Answer the first symptomatic related survey at the randomization visit (V0) and the following ones in the morning when they wake up, the last survey will be answered at the final visit (day 7)

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

Primary outcomes:
measure: Assess the improvement in symptoms, comparing the percentage change through the Jackson score
timeFrame: 7 days
measure: Number of participants with treatment-related adverse events through the patient's diary record, by treatment group
timeFrame: 7 days
Secondary outcomes:
measure: Assess the subjective change in patients in relation to quality of life through the modified Likert score
timeFrame: 7 days
measure: Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale
timeFrame: 7 days
measure: Assess the improvement in health status through the modified Likert Scale
timeFrame: 7 days
Other outcomes:
measure: Assess the percentage of patients with febrile episodes (≥38°C) during the intervention
timeFrame: 7 days
measure: To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment
timeFrame: 7 days
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Oaxaca Site Management Organization
name: Ana Luara Flores-Barranco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Investigación y Avances Médicos Especializados
name: Juan A Becerra-Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIMA
name: Salvador Perez-Jaime, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mérida Investigación Clínica
name: Victor C Bohorquez-Lopez, MD
role: PRINCIPAL_INVESTIGATOR
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