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NCT05783492

INK Feasibility Study

Withdrawn Phase 3 Last updated 24 March 2023
What this trial tests

Phase 3 trial testing Intranasal ketamine in Procedural Sedation. Withdrawn.

Timeline
1 January 2024
Primary endpoint
31 March 2024
30 April 2024

Quick facts

Lead sponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
PhasePhase 3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Start date1 January 2024
Primary completion31 March 2024
Estimated completion30 April 2024

Drugs / interventions tested

Conditions studied

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

Adults 7 to 17, any sex, with Procedural Sedation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The trial (Intranasal ketamine for procedural sedation in children: a randomized controlled non-inferiority multicenter trial or INK; ReDA 5496; CTO 1545) is being scheduled for launch in Spring 2019. Due to the possibility of failure of the experimental intervention (intranasal ketamine 10 mg/kg), the data safety monitoring board (DSMB) and statistical methods team would like to explore the possibility of developing a stopping rule to prevent patients from being enrolled in a futile trial and conserve resources. In order to get accurate data to develop a statistically robust stopping rule, it is necessary to conduct a cohort study of patients that receive the INK trial's experimental intervention and according to it's protocol. This cohort study will help estimate the chance of adequate sedation and inform the final dosing protocol for the INK trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Intranasal ketamine

Trials testing the same drug.

Other recruiting trials for Procedural Sedation

Currently open trials in the same condition.

Other London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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/NCT05783492.

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