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NCT03705273

Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Terminated Phase 4 Results posted Last updated 8 November 2021
What this trial tests

Phase 4 trial testing Dexamethasone IV for PO in Asthma in 40 participants. Terminated before completion.

Timeline
23 October 2018
Primary endpoint
2 October 2020
2 October 2020

Quick facts

Lead sponsorVanderbilt University Medical Center
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date23 October 2018
Primary completion2 October 2020
Estimated completion2 October 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 1 to 7, any sex, with Asthma or Croup. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Nausea Primary · 1 hour

Presence of nausea after medication administration (yes/no) measured by participant self-report

GroupValue95% CI
Dexamethasone Tablets3
Dexamethasone IV for PO0
Number of Participants Requiring Second Dose of Dexamethasone Secondary · 1 hour

Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose

GroupValue95% CI
Dexamethasone Tablets0
Dexamethasone IV for PO0

Sponsor's own description

Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03705273.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing