Actively Recruiting
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
Led by Laboratorios Silanes S.A. de C.V. · Updated on 2025-04-08
70
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.
CONDITIONS
Official Title
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and able to provide written informed consent
- Clinical diagnosis of active allergic rhinitis at study entry
- Moderate to severe nasal symptoms with a Total Nasal Symptom Score (TNSS) 65
- Women of childbearing potential must use acceptable contraception if sexually active
- Investigator's opinion that patient may benefit from the investigational product
You will not qualify if you...
- Medical contraindication to the investigational drug
- Allergy or hypersensitivity to study medications or related products
- Nasal trauma within the past week
- Positive pregnancy test, pregnant, breastfeeding, or planning pregnancy during the study
- Acute or chronic respiratory infections (e.g., common cold, influenza, pneumonia, bronchitis, chronic sinusitis)
- History of non-allergic rhinitis or related nasal conditions
- History of nasal polyposis, primary ciliary dyskinesia syndrome, or NARES
- Current smokers or history of alcohol/drug abuse in past year
- History of seizure disorders or generalized tonic-clonic seizures
- Chronic hepatic failure classified as Child-Pugh C
- Chronic renal failure with glomerular filtration rate < 30 mL/min/1.73 m8
- Any condition affecting prognosis or preventing outpatient management
- Severe, progressive, unstable, or advanced disease interfering with study evaluations
- Cancer patients (except basal cell skin cancer) or poor prognosis with life expectancy under one year
- Active participation in another clinical trial within past two weeks
- Patients influenced by study participation (e.g., employees, incarcerated individuals)
- Symptoms or recent exposure related to active COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000
Actively Recruiting
Research Team
J
Jorge A Gonzalez, PhD
CONTACT
Y
Yulia Romero-Antonio, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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