Prevention of Posttraumatic Contractures with Ketotifen II (PERK2)
Abstract
Regulatory approvals - US Food and Drug Administration, USAMRMC Human Research Protections Office (HRPO), Health Canada - have been completed for 14 participating sites. Remaining 3sites are poised for approval during Q1 of year 4. 14 of the participating sites have received ethics approval. Site initiation visits were completed at 6 sites, with 11 actively recruiting before COVID-19 lockdown. Bay Area Research Logistics (BARL) has completed shipment of medication to 11 sites, with plans on shipping medication to 3 more sites duringQ1 or year 4. These efforts have led to active sites successfully recruiting and randomizing51 participants. Screening/recruitment efforts have been limited due to COVID-19 restrictions at all sites of interest. Only 6 sites have been approved for trial restart by the local operating officials. However, all sites with active participants were able to safely continue data collection efforts. Site contract negotiations have been completed at 16 sites, with the last remaining to be done during Q1 of Year 4. 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, with plans of holding first meeting during Q1 of Year 4. One manuscript was published during this reporting period.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1116880
Entities
People
- Kevin A Hildebrand