Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
NCT ID: NCT06531707
Last Updated: 2024-08-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
177 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-05-20
Study Completion Date
2025-02-20
Brief Summary
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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.
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Detailed Description
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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)
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)
Conditions
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Common Cold
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Ibuprofen + Loratadine
Administered orally (suspension), 5 mL twice a day, for 7 days.
Group Type
EXPERIMENTAL
Ibuprofen + Loratadine fixed dose
Intervention Type
DRUG
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
Ibuprofen
Administered orally (suspension), 20 mL, twice a day for 7 days.
Group Type
ACTIVE_COMPARATOR
Ibuprofen
Intervention Type
DRUG
Suspension 2,000 mg / 100 mL, 20 mL twice a day
Loratadine
Administered orally (suspension), 5 mL, twice a day for 7 days
Group Type
ACTIVE_COMPARATOR
Loratadine
Intervention Type
DRUG
Suspension 1 mg / 1 mL, 5 mL twice a day
Interventions
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Ibuprofen + Loratadine fixed dose
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
Intervention Type
DRUG
Ibuprofen
Suspension 2,000 mg / 100 mL, 20 mL twice a day
Intervention Type
DRUG
Loratadine
Suspension 1 mg / 1 mL, 5 mL twice a day
Intervention Type
DRUG
Other Intervention Names
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Ibu+Lora
Ibu
Lora
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ana Luara Flores-Barranco, MD
Role: PRINCIPAL_INVESTIGATOR
Oaxaca Site Management Organization
Juan A Becerra-Hernández, MD
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación y Avances Médicos Especializados
Salvador Perez-Jaime, MD
Role: PRINCIPAL_INVESTIGATOR
CIMA
Victor C Bohorquez-Lopez, MD
Role: PRINCIPAL_INVESTIGATOR
Mérida Investigación Clínica
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Site Status
RECRUITING
Countries
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Mexico
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SIL-30700-III-23(1)
Identifier Type: -
Identifier Source: org_study_id
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A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
NCT03861611
COMPLETED
PHASE4
Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers
NCT00945178
TERMINATED
PHASE1
Ibuprofen vs Acetaminophen for AMS Prevention
NCT02244437
COMPLETED
PHASE4
Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)
NCT01576809
COMPLETED
PHASE3
Actual Use Trial of Ibuprofen 400 mg
NCT02294019
COMPLETED
PHASE3
Adult Oral Ibuprofen Study for ED Pain Patients
NCT03441269
COMPLETED
PHASE4
A Randomized Trial of NSAID Dosing Strategies
NCT05239767
COMPLETED
PHASE4
Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain
NCT05013567
UNKNOWN
PHASE3
Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions
NCT03561558
COMPLETED
PHASE1
Ibuprofen With or Without Acetaminophen for Low Back Pain
NCT03554018
COMPLETED
PHASE3