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NCT04673422
Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients
Completed
Phase 2, PHASE3
Last updated 18 July 2023
What this trial tests
Phase 2, PHASE3 trial testing Montelukast in Dengue in 358 participants. Completed in 17 June 2023.
Timeline
15 January 2021
Primary endpoint
17 June 2023
17 June 2023
17 June 2023
Quick facts
| Lead sponsor | Phramongkutklao College of Medicine and Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 358 |
| Start date | 15 January 2021 |
| Primary completion | 17 June 2023 |
| Estimated completion | 17 June 2023 |
| Sites | 4 locations across Thailand |
Drugs / interventions tested
- Montelukast (montelukast) — full drug profile →
- Placebo
Conditions studied
- Dengue — all drugs for Dengue →
- Dengue With Warning Signs — all drugs for Dengue With Warning Signs →
- Dengue Shock Syndrome — all drugs for Dengue Shock Syndrome →
Sponsor
Phramongkutklao College of Medicine and Hospital
Who can join
18 and older, any sex, with Dengue or Dengue With Warning Signs. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to determine the efficacy of montelukast in reducing the incidence of dengue warning signs in adult dengue patients.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dengue.
Paz-Bailey G, Adams LE, Deen J, Anderson KB, et al · · 2024 · cited 177× · PMID 38280388 · DOI 10.1016/s0140-6736(23)02576-x -
Dengue: Update on Clinically Relevant Therapeutic Strategies and Vaccines.
Palanichamy Kala M, St John AL, Rathore APS. · · 2023 · cited 64× · PMID 37124673 · DOI 10.1007/s40506-023-00263-w -
Inhibitory Potential of Chromene Derivatives on Structural and Non-Structural Proteins of Dengue Virus.
Dharmapalan BT, Biswas R, Sankaran S, Venkidasamy B, et al · · 2022 · cited 7× · PMID 36560664 · DOI 10.3390/v14122656 -
Effect of montelukast in preventing dengue with warning signs among patients with dengue: A multicenter, randomized, double-blind, placebo-controlled trial.
Nitinai N, Nasomsong W, Chuerboonchai W, Tweekittikul A, et al · · 2024 · cited 4× · PMID 38306389 · DOI 10.1371/journal.pntd.0011927
Verify or expand the search:
- PubMed search for NCT04673422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Phramongkutklao College of Medicine and Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04673422 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Phramongkutklao College of Medicine and Hospital
- Last refreshed: 18 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04673422.
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