Prevention of Post Traumatic Contractures with Ketotifen II (PERK II)
Abstract
380 participants recruited by September 29, 2023. The 12% withdrawal rate outlined in the protocol has been met, meaning that we may encounter issues reaching our 80% power. Appropriate regulatory submissions have been completed and our REB has approved enrolling past our 384 sample size to offset these withdrawals. Screening and enrollment procedures will continue until December 21st, 2023. With our current 10 participant enrollments per month average, we may reach close to 400 participants. Health Canada Sponsor inspection has been completed and closed successfully. Royal Columbian Hospital, site 10, has responded to their site level inspection by Health Canada, expecting a response in October 2023.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1220617
Entities
People
- Kevin A Hildebrand
Organizations
- University of Calgary