NCT06246331

Brief Summary

This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

December 20, 2023

Last Update Submit

February 4, 2024

Conditions

Reversal of Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)

    Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

    after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged 19 years or older

You may qualify if:

  • Adults over 19 years of age
  • Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

You may not qualify if:

  • Pregnant women or nursing women
  • Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

RECRUITING

Study Officials

  • Sangseok Lee

    Inje University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangseok Lee

CONTACT

+82-2-950-1989s2248@paik.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2023

First Posted

February 7, 2024

Study Start

July 21, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

KR(1)