CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
ADV6209 (=gamma-cyclodextrin-Midazolam) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03931057
NCT03931057Phase 4Completed
CompareCT.gov

The Use of ADV6209 for Premedication in Pediatric Anesthesia: a Controlled, Randomized, Double Blinded Study

Medical University of Vienna·interventional·Posted Apr 29, 2019·Updated Feb 16, 2022

In Brief

A Phase 4 clinical trial evaluating ADV6209 (=gamma-cyclodextrin-Midazolam) and Midazolam for Preanesthetic Medication. Completed, enrolled 80 participants across 1 site.

Detailed Summary

To evaluate the effect of ADV6209, a new oral Midazolam formulation, on preoperative anxiety and sedation levels in paediatric anaesthesia Primary Objective: Sedation score (mYPAS) 30 min after administration of the premedication drug Secondary Objective: Acceptance of anaesthesia mask induction Acceptance of oral administration of the premedication drug

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreanesthetic Medication
CountriesAustria
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 29, 2019
Enrollment StartNov 16, 2020
Primary CompletionSep 17, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.2 years ago

Interventions

ADV6209 (=gamma-cyclodextrin-Midazolam)drug

30 min. before anesthesia children have to swallow the anxiolytic drug (ADV6209)

Midazolamdrug

30 min. before anesthesia children have to swallow the anxiolytic drug Midazolam