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.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2023
Accession Number
AD1220617

Entities

People

  • Kevin A Hildebrand

Organizations

  • University of Calgary

Tags

Fields of Study

  • Medicine

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