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Clinical trial

Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients: a Multicenter Randomized, Double-blind, Placebo Controlled, Superiority Trial

ID
Name
AMEDDengue2020
Description
This study aims to determine the efficacy of montelukast in reducing the incidence of dengue warning signs in adult dengue patients.
Trial arms
Trial start
2021-01-15
Estimated PCD
2023-06-17
Trial end
2023-06-17
Status
Completed
Phase
Early phase I
Treatment
Montelukast
A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
Arms:
Montelukast
Placebo
A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
Arms:
Placebo
Size
358
Primary endpoint
Rate of dengue with warning signs
14 days or until the discontinuation of the follow up appointment by the attending physicians, whichever is shorter.
Eligibility criteria
Inclusion Criteria: * at least 18 years old * diagnosis of dengue * positive NS1 antigen or polymerase chain reaction (PCR) test Exclusion Criteria: * any warning sign of dengue * concurrent diagnosis of other causes of fever, such as malaria or heat stroke * pregnancy * being unable to take medication by mouth * critical illness needing intubation or admission to an intensive care unit * being unable to communicate * other indication of montelukast
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a randomized, prospective, 2-arm, parallel-group, double-blind, placebo-controlled superiority trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 358, 'type': 'ACTUAL'}}
Updated at
2023-07-18

1 organization

1 product

1 drug

2 indications

Organization
Phramongkutklao College of Medicine and Hospital
Product
Montelukast
Indication
Dengue
Indication
Dengue Shock Syndrome
Drug
Varlilumab