A Phase 3 interventional study of Ibuprofen + Loratadine fixed dose and Ibuprofen in Common Cold, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 3, Interventional, and Treatment
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.
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:
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 177 is above the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Laboratorios Silanes S.A. de C.V. is the lead sponsor of 45 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered orally (suspension), 5 mL twice a day, for 7 days.
Drug: Ibuprofen + Loratadine fixed dose
Administered orally (suspension), 20 mL, twice a day for 7 days.
Drug: Ibuprofen
Administered orally (suspension), 5 mL, twice a day for 7 days
Drug: Loratadine
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
Also known as: Ibu+Lora
Suspension 2,000 mg / 100 mL, 20 mL twice a day
Also known as: Ibu
Suspension 1 mg / 1 mL, 5 mL twice a day
Also known as: Lora
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.
Time frame: 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
Time frame: 7 days
Assess the subjective change in patients in relation to quality of life through the modified Likert score
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.
Time frame: 7 days
Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale
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.
Time frame: 7 days
Assess the improvement in health status through the modified Likert Scale
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.
Time frame: 7 days
Assess the percentage of patients with febrile episodes (≥38°C) during the intervention
The patient will report the presence of fever during the intervention, quantified with a thermometer.
Time frame: 7 days
To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment
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
Time frame: 7 days
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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