The common cold.
Terho Heikkinen, Asko Järvinen
https://pubmed.ncbi.nlm.nih.gov/12517470Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06531707
Efficacy and Safety of Ibuprofen/Loratadine Combination Versus Ibuprofen or Loratadine Alone for Symptomatic Treatment of the Common Cold
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2024-08-02
177
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare the safety and effectiveness of a combination drug treatment using Ibuprofen and Loratadine versus each drug alone for relieving symptoms of the common cold. It is a phase III, randomized, double-blind clinical trial involving multiple centers. Researchers will closely monitor any adverse effects related to these treatments during the study. Participants will be randomly assigned to one of three groups receiving either the Ibuprofen and Loratadine combination, Ibuprofen alone, or Loratadine alone. All medications are given orally as suspensions twice daily for seven days. The study includes a screening visit on day 0 and a follow-up visit on day 7, during which participants will complete symptom surveys daily upon waking. During the trial, participants will complete symptom assessments using the Jackson score and other subjective scales to measure quality of life and health status. Researchers will collect data on symptom improvement and record any treatment-related side effects through patient diaries. The study lasts seven days, with safety and symptom changes closely followed from enrollment to the final visit.
CONDITIONS
Brief Title
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Agree to participate in the study and provide written informed consent
- Have at least 6 points on the Jackson scale based on symptoms like sneezing, runny nose, nasal obstruction, sore throat, cough, headache, malaise, and chills
- Symptoms of the common cold started no more than 3 days before enrollment
- Women of childbearing potential use medically acceptable contraception
- Treatment with the study drug is indicated by the Principal Investigator or treating physician and may offer clinical benefit
You will not qualify if you...
- Suspected bacterial respiratory infection or diseases like rhinosinusitis, lower respiratory tract disease, or acute otitis media
- Participation in another clinical trial with investigational treatment within the past 4 weeks
- Employment or other relationships that could influence study participation
- Diseases affecting prognosis or preventing outpatient care, such as end-stage cancer, organ failure, mental illness, or planned surgery/hospitalization
- Any condition posing risk or confusing safety and efficacy assessment as judged by the Investigator
- Contraindications to the study drugs
- Allergy or hypersensitivity to Ibuprofen, Loratadine, or related products
- Pregnant, breastfeeding, or planning pregnancy during the study
- Significant gastrointestinal diseases like gastric ulcer, Crohn's disease, or ulcerative colitis
- Chronic liver failure (Child-Pugh A, B, or C)
- Acute renal failure with low filtration rate
- History of alcohol or drug abuse in the past year
- Symptoms or recent contact suggesting COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - 7 days
Participants are randomized to receive one of three oral suspensions twice a day for 7 days to treat common cold symptoms.
1 baseline visit (day 0) and 1 follow-up visit (day 7)
Follow-up
Duration - 7 days
Participants complete daily symptom surveys each morning and report any adverse events during the 7-day treatment period.
Daily symptom surveys completed at home
Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
Loading map...
Research Team
J
Jorge A Gonzalez, PhD
Y
Yulia Romero-Antonio, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Excessive antibiotic use for acute respiratory infections in the United States.
R Gonzales, D C Malone, J H Maselli...
https://pubmed.ncbi.nlm.nih.gov/11512079The common cold.
G L Kirkpatrick
https://pubmed.ncbi.nlm.nih.gov/8890137The economic burden of non-influenza-related viral respiratory tract infection in the United States.
A Mark Fendrick, Arnold S Monto, Brian Nightengale...
https://pubmed.ncbi.nlm.nih.gov/12588210The common cold: potential for future prevention or cure.
Maria Passioti, Paraskevi Maggina, Spyridon Megremis...
https://pubmed.ncbi.nlm.nih.gov/24415465Aerosol transmission of rhinovirus colds.
E C Dick, L C Jennings, K A Mink...
https://pubmed.ncbi.nlm.nih.gov/3039011Seasonality and selective trends in viral acute respiratory tract infections.
Patrick D Shaw Stewart
https://pubmed.ncbi.nlm.nih.gov/26608252Studies of the community and family: acute respiratory illness and infection.
A S Monto
https://pubmed.ncbi.nlm.nih.gov/7713184[Not Available].
Nancy López Olmedo, Dalia Stern, Carolina Pérez Ferrer...
https://pubmed.ncbi.nlm.nih.gov/33989481Exercise, upper respiratory tract infection, and the immune system.
D C Nieman
https://pubmed.ncbi.nlm.nih.gov/8164529