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

July 31, 2024 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

177

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Recruiting
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana L Flores-Barranco, MD
        • Principal Investigator:
          • Juan A Becerra-Hernández, MD
        • Principal Investigator:
          • Salvador Pérez-Jaime, MD
        • Principal Investigator:
          • Victor C Bohórquez-López, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen + Loratadine
Administered orally (suspension), 5 mL twice a day, for 7 days.
Drug: Ibuprofen + Loratadine fixed dose
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
Other Names:
  • Ibu+Lora
Active Comparator: Ibuprofen
Administered orally (suspension), 20 mL, twice a day for 7 days.
Drug: Ibuprofen
Suspension 2,000 mg / 100 mL, 20 mL twice a day
Other Names:
  • Ibu
Active Comparator: Loratadine
Administered orally (suspension), 5 mL, twice a day for 7 days
Drug: Loratadine
Suspension 1 mg / 1 mL, 5 mL twice a day
Other Names:
  • Lora

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the improvement in symptoms, comparing the percentage change through the Jackson score
Time Frame: 7 days
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
Time Frame: 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the subjective change in patients in relation to quality of life through the modified Likert score
Time Frame: 7 days

To compare quality of life measured as a difference in the modified Likert score by treatment group during the 7 days after starting treatment with respect to the baseline measurement. The patient will answer the scale daily.

The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to quality of life. The possible answers go from No interference to Severe interference.
7 days
Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale
Time Frame: 7 days

Assess the improvement in symptoms measured as the proportion of patients who present a change in the Global Subjective Scale during the 7 days after starting treatment with respect to the baseline measurement.

The subjective global scale for symptom improvement compares with the score of the previous day to determine health status daily. Is consists of 1 question related to the progress in the symptoms presentation, the answers go from much better to really worse.
7 days
Assess the improvement in health status through the modified Likert Scale
Time Frame: 7 days

To compare improvement in health status as a difference in the modified Likert scale by treatment group during the 7 days after starting treatment with respect to the baseline measurement.The patient will answer the scale daily.

The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to the health status of the patient. The possible answers go from Not feeling sick to feeling to Severely sick.
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the percentage of patients with febrile episodes (≥38°C) during the intervention
Time Frame: 7 days
The patient will report the presence of fever during the intervention, quantified with a thermometer.
7 days
To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment
Time Frame: 7 days
Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Ana Luara Flores-Barranco, MD, Oaxaca Site Management Organization
  • Principal Investigator: Juan A Becerra-Hernández, MD, Centro de Investigacion y Avances Medicos Especializados
  • Principal Investigator: Salvador Perez-Jaime, MD, CIMA
  • Principal Investigator: Victor C Bohorquez-Lopez, MD, Merida Investigación Clínica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Estimated)

January 20, 2025

Study Completion (Estimated)

February 20, 2025

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30700-III-23(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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