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Montelukast for Preventing Dengue Warning Signs
NCT04673422Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2021
- Primary completion
- Jun 2023
- Countries
- 1
- Sponsor
- Phramongkutklao College of Medicine and Hospital
- Modality
- Small Molecules
- Drugs
- montelukast
- Conditions
- dengue fever
01
Overview
Phase 3, randomised, double-blind trial in dengue fever comparing Montelukast with Placebo (2 arms). Primary endpoint: Rate of dengue with warning signs at 14 days. Started Jan 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Montelukast
Montelukast 10 mg tablet daily.
Placebo
Placebo tablet daily.
03
Who it enrols
Adult patients (>=18 years) with confirmed dengue (positive NS1 or PCR) without warning signs.
04
Endpoints
Primary
Rate of dengue with warning signs
Secondary
Rate of each component of composite outcome of dengue with warning signs
Rate of hospitalization
Length of hospital stay
Rate of severe dengue
Rate of dengue shock
30-day mortality
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