Common ColdPhase 3NCT06531707
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
A Phase 3 study testing Ibuprofen + Loratadine fixed dose, Ibuprofen and Loratadine in people with Common Cold, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Ibuprofen + Loratadine fixed dose, Ibuprofen and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteMexico
- Study dates
- 24 Jun 2024to 12 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Common Cold
- Being tested
- Ibuprofen + Loratadine fixed dose, Ibuprofen, Loratadine
- Keywords
- Common Cold, Flu, Ibuprofen, Loratadine
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen + Loratadine fixed doseDrug
Also called Ibu+Lora
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
IbuprofenDrug
Also called Ibu
Suspension 2,000 mg / 100 mL, 20 mL twice a day
LoratadineDrug
Also called Lora
Suspension 1 mg / 1 mL, 5 mL twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen + Loratadine | Experimental | Administered orally (suspension), 5 mL twice a day, for 7 days. Receives: Drug: Ibuprofen + Loratadine fixed dose |
| Ibuprofen | Active comparator | Administered orally (suspension), 20 mL, twice a day for 7 days. Receives: Drug: Ibuprofen |
| Loratadine | Active comparator | Administered orally (suspension), 5 mL, twice a day for 7 days Receives: Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start24 Jun 2024
- Primary completion20 Jan 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Luara Flores-Barranco, MD, Principal investigator, Oaxaca Site Management OrganizationJuan A Becerra-Hernández, MD, Principal investigator, Centro de Investigación y Avances Médicos EspecializadosSalvador Perez-Jaime, MD, Principal investigator, CIMAVictor C Bohorquez-Lopez, MD, Principal investigator, Mérida Investigación Clínica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531707
- Sponsor's protocol ID
- SIL-30700-III-23(1)
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9.
PubMed 12517470Gonzales R, Malone DC, Maselli JH, Sande MA. Excessive antibiotic use for acute respiratory infections in the United States. Clin Infect Dis. 2001 Sep 15;33(6):757-62. doi: 10.1086/322627. Epub 2001 Aug 21.
PubMed 11512079Kirkpatrick GL. The common cold. Prim Care. 1996 Dec;23(4):657-75. doi: 10.1016/s0095-4543(05)70355-9.
PubMed 8890137Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487.
PubMed 12588210Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5.
PubMed 24415465Dick EC, Jennings LC, Mink KA, Wartgow CD, Inhorn SL. Aerosol transmission of rhinovirus colds. J Infect Dis. 1987 Sep;156(3):442-8. doi: 10.1093/infdis/156.3.442.
PubMed 3039011Shaw Stewart PD. Seasonality and selective trends in viral acute respiratory tract infections. Med Hypotheses. 2016 Jan;86:104-19. doi: 10.1016/j.mehy.2015.11.005. Epub 2015 Nov 6.
PubMed 26608252Monto AS. Studies of the community and family: acute respiratory illness and infection. Epidemiol Rev. 1994;16(2):351-73. doi: 10.1093/oxfordjournals.epirev.a036158.
PubMed 7713184Lopez Olmedo N, Stern D, Perez Ferrer C, Gonzalez Morales R, Canto Osorio F, Barrientos Gutierrez T. Revision rapida: probabilidad de contagio por infecciones respiratorias agudas en el transporte publico colectivo. Salud Publica Mex. 2021 Feb 26;63(2, Mar-Abr):225-231. doi: 10.21149/12027. Spanish.
PubMed 33989481Nieman DC. Exercise, upper respiratory tract infection, and the immune system. Med Sci Sports Exerc. 1994 Feb;26(2):128-39. doi: 10.1249/00005768-199402000-00002.
PubMed 8164529Pitkaranta A, Nokso-Koivisto J, Jantti V, Takala A, Kilpi T, Hovi T. Lowered yields of virus-induced interferon production in leukocyte cultures and risk of recurrent respiratory infections in children. J Clin Virol. 1999 Dec;14(3):199-205. doi: 10.1016/s1386-6532(99)00056-6.
PubMed 10614857Turner RB. Epidemiology, pathogenesis, and treatment of the common cold. Ann Allergy Asthma Immunol. 1997 Jun;78(6):531-9; quiz 539-40. doi: 10.1016/S1081-1206(10)63213-9.
PubMed 9207716Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.
PubMed 16253889Douglas RG Jr, Alford RH, Cate TR, Couch RB. The leukocyte response during viral respiratory illness in man. Ann Intern Med. 1966 Mar;64(3):521-30. doi: 10.7326/0003-4819-64-3-521. No abstract available.
PubMed 4286006Hendley JO. Epidemiology, pathogenesis, and treatment of the common cold. Semin Pediatr Infect Dis. 1998 Jan;9(1):50-55. doi: 10.1016/S1045-1870(98)80051-4. Epub 2006 Jun 3.
PubMed 32288450