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Ibuprofen/Loratadine Fixed-dose Combination for the Common Cold
NCT06531707Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2024
- Primary completion
- Jan 2025
- Countries
- 1
- Sponsor
- Laboratorios Silanes
- Modality
- Orthosteric Ligands
- Drugs
- ibuprofenloratadine
- Conditions
- common cold
01
Overview
Phase 3, randomised, double-blind trial in common cold comparing Ibuprofen + Loratadine, Ibuprofen and Loratadine (3 arms). Primary endpoints: Percentage change in Jackson score at 7 days and Number of participants with treatment-related adverse events at 7 days. Started Jun 2024; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Ibuprofen + Loratadine
Administered orally (suspension), 5 mL twice a day, for 7 days.
Ibuprofen
Administered orally (suspension), 20 mL, twice a day for 7 days.
Loratadine
Administered orally (suspension), 5 mL, twice a day for 7 days
03
Who it enrols
Patients with common cold symptoms for max 3 days and Jackson score >=6, excluding those with suspected bacterial or COVID-19 infections, severe systemic diseases, GI diseases, chronic liver failure, or acute renal failure.
04
Endpoints
Primary
Percentage change in Jackson score
Number of participants with treatment-related adverse events
Secondary
Subjective change in quality of life through the modified Likert score
Subjective change in symptoms through the Subjective Global Scale
Improvement in health status through the modified Likert Scale
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