Clinical trial • Phase IV • Other
Sugammadex for Neuromuscular block
Phase IV trial of Sugammadex for Neuromuscular block. Randomised. 80 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Neuromuscular block
- Trial Stage
- Phase IV
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 06-03-2025
- First CTIS Authorization Date
- 13-06-2025
Trial design
Randomised Phase IV trial across 1 site in Hungary.
- Randomised
- Yes
- Target Sample Size
- 80
Eligibility
Recruits 80 No vulnerable populations selected (isVulnerablePopulationSelected: false)..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false).
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 44
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 80
Hungary
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 99
- Number Of Sites
- 1
- Number Of Participants
- 80
Sites
- Site Name
- University Of Debrecen
- Department Name
- FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
- Principal Investigator Name
- László Asztalos
- Principal Investigator Email
- asztaloslasz@gmail.com
- Contact Person Name
- László Asztalos
- Contact Person Email
- asztaloslasz@gmail.com
Sponsor
Primary sponsor
- Full Name
- University Of Debrecen
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Hungary
Investigational products
- Investigational Product Name
- Sugammadex
- Active Substance
- Sugammadex
- Modality
- Other
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