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

Laboratorios Silanes

Status and phase: Enrolling; Phase 3

Conditions: Common Cold

Treatments: Drug: Loratadine; Drug: Ibuprofen; Drug: Ibuprofen + Loratadine fixed dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06531707

SIL-30700-III-23(1)

Details and patient eligibility

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.

Full 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)

Enrollment: 177 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 3 patient groups

Ibuprofen + Loratadine

Experimental group

Description:

Administered orally (suspension), 5 mL twice a day, for 7 days.

Treatment:

Drug: Ibuprofen + Loratadine fixed dose

Ibuprofen

Active Comparator group

Description:

Administered orally (suspension), 20 mL, twice a day for 7 days.

Treatment:

Drug: Ibuprofen

Loratadine

Active Comparator group

Description:

Administered orally (suspension), 5 mL, twice a day for 7 days

Treatment:

Drug: Loratadine