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PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
Sponsor: University of Calgary
Summary
PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) is a Phase III randomized, controlled, double blinded multicenter trial with 3 parallel groups (Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) and a primary endpoint of elbow extension-flexion range of motion (ROM) arc at 12 weeks post-randomization.
Key Details
Gender
All
Age Range
18 Years - 95 Years
Study Type
INTERVENTIONAL
Enrollment
395
Start Date
2019-04-26
Completion Date
2024-12-17
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
Lactose Placebo
One capsule by mouth twice per day
Ketotifen Fumarate 2mg
2 mg tablets (over-encapsulated into one capsule) by mouth twice per day
Ketotifen Fumarate 5mg
5 mg tablets (over-encapsulated into one capsule) by mouth twice per day
Locations (15)
University of Maryland Medical Centre
Baltimore, Maryland, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Peter Lougheed Centre
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Sturgeon Community Hospital
St. Albert, Alberta, Canada
Royal Columbia Hospital
New Westminster, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Health Care London
London, Ontario, Canada
The Ottawa General Hospital
Ottawa, Ontario, Canada
The Ottawa Civic Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada