Prevention of Post-Traumatic Contractures with Ketotifen 2 (PERK 2)
Abstract
Regulatory approvals - US Food and Drug Administration, USAMRMC Human Research Protections Office (HRPO), Health Canada have been completed for 15 participating sites. 16 of the participating sites have received ethics approval. Site initiation visits were completed at 2 sites, with 15 actively recruiting. Bay Area Research Logistics (BARL) has completed shipment of medication to 15 sites, with plans on shipping medication to 1 more site during Q1 of year 5. These efforts have led to active sites successfully recruiting and randomizing 161 participants. Site contract negotiations have been completed for all 17 sites. Bi-weekly safety summary meetings are being held with local Research Monitor to review AE/SAEs. Updated versions of charters for Data Monitoring Committee (DMC), Trial Steering Committee (TSC), and Trial Management Group (TMG) were finalized. Monthly TMG meetings are being held, with TSC meetings occurring every three months. DMC membership has been finalized, and an introductory meeting held with stakeholders. First DMC meeting is scheduled to occur during Year 5, Q1. A 1 year No Cost Extension was granted by U.S. Army Medical Research and Development Command to continue enrollment and follow up procedures for the trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1156784
Entities
People
- Kevin A Hildebrand
Organizations
- University of Alberta