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

Last updated: July 31, 2024
Sponsor: Laboratorios Silanes S.A. de C.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Common Cold

Acute Rhinitis

Treatment

Loratadine

Ibuprofen + Loratadine fixed dose

Ibuprofen

Clinical Study ID

NCT06531707
SIL-30700-III-23(1)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andquestioning (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

Exclusion Criteria:

  • Patients in whom respiratory symptoms are suspected to be of bacterial origin andgenerate a clinical picture compatible with: Rhinosinusitis (muco-purulentdischarge, headache or facial pain, etc.), lower respiratory tract disease (wheezing, crackles, productive cough, etc.), acute otitis media (otalgia, purulentdischarge from the ear, auditory discomfort, etc.).

  • Patients participating in another clinical trial involving an investigationaltreatment or participation in one within 4 weeks prior to study start

  • Patients in whom participation in the study may be influenced (employmentrelationship with the research site or sponsor, inmates, etc.)

  • At medical discretion, a disease that affects prognosis and prevents outpatientmanagement, for example, but not limited to: end-stage cancer, kidney, heart,respiratory or liver failure, mental illness or with scheduled surgical or hospitalprocedures

  • History/presence of any disease or condition that, in the opinion of theInvestigator, could pose a risk for the patient or confusing the efficacy and safetyof 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 studydrugs, related products or excipients (Ibuprofen of Loratadine)

  • Pregnant women, women breastfeeding or planning a pregnancy during the conductingthe study

  • Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn'sdisease, 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 Design

Total Participants: 177
Treatment Group(s): 3
Primary Treatment: Loratadine
Phase: 3
Study Start date:
May 20, 2024
Estimated Completion Date:
February 20, 2025

Study 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)

Connect with a study center

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000
    Mexico

    Active - Recruiting

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