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

NCT06531707 | Recruiting Phase 3 DMC

• 1 other identifier: SIL-30700-III-23(1)
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Keywords

Common Cold; Flu; Ibuprofen; Loratadine

Outcome Measures

Primary Outcomes (2)

• Assess the improvement in symptoms, comparing the percentage change through the Jackson score

  The Jackson score is calculated by summing 8 symptom scores (sneezing, headache, malaise, chilliness, nasal discharge, nasal obstruction, sore throat and cough), rated as 0=absent, 1=mild, 2=moderate, and 3=severe.

  7 days

• Number of participants with treatment-related adverse events through the patient's diary record, by treatment group

  To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher

  7 days

Secondary Outcomes (3)

• Assess the subjective change in patients in relation to quality of life through the modified Likert score

  7 days

• Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale

  7 days

• Assess the improvement in health status through the modified Likert Scale

  7 days

Other Outcomes (2)

• Assess the percentage of patients with febrile episodes (≥38°C) during the intervention

  7 days

• To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment

  7 days

Study Arms (3)

Ibuprofen + Loratadine

EXPERIMENTAL

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

Drug: Ibuprofen + Loratadine fixed dose

Ibuprofen

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Loratadine

ACTIVE COMPARATOR

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

Drug: Loratadine

Interventions

Ibuprofen + Loratadine fixed dose DRUG

Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day

Also known as: Ibu+Lora

Ibuprofen + Loratadine

Ibuprofen DRUG

Suspension 2,000 mg / 100 mL, 20 mL twice a day

Also known as: Ibu

Ibuprofen

Loratadine DRUG

Suspension 1 mg / 1 mL, 5 mL twice a day

Also known as: Lora

Loratadine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

RECRUITING

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MeSH Terms

Conditions

Common Cold; Influenza, Human

Interventions

Ibuprofen; Loratadine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Ana Luara Flores-Barranco, MD

  Oaxaca Site Management Organization

  PRINCIPAL INVESTIGATOR

• Juan A Becerra-Hernández, MD

  Centro de Investigación y Avances Médicos Especializados

  PRINCIPAL INVESTIGATOR

• Salvador Perez-Jaime, MD

  CIMA

  PRINCIPAL INVESTIGATOR

• Victor C Bohorquez-Lopez, MD

  Mérida Investigación Clínica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A Gonzalez, PhD

CONTACT

5254883785; jogonzalez@silanes.com.mx

Yulia Romero-Antonio, B.S.

CONTACT

5254883785; yromero@silanes.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 1, 2024
• Study Start: May 20, 2024
• Primary Completion: January 20, 2025
• Study Completion: February 20, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)