PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
Completed · Phase 3 · Has a placebo group
Conditions studied: Elbow Fracture, Elbow Injury, Elbow Dislocation
In brief
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 facts
- Study ID
- NCT03582176
- Run by
- University of Calgary
- People needed
- 395
- Starts
- 2019-04-26
- Expected to finish
- 2024-12-17
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old; skeletally mature with no growth plates in the elbow
- Distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2U1 or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included)
- Operative treatment of the elbow fracture or dislocation
- Injury ≤ 10 days
- Participant has a negative urine or blood serum pregnancy test
You may not qualify if…
- Pre-existing elbow contracture
- Elbow arthritis (osteoarthritis, inflammatory arthritis, or nonspecific monoarticular arthritis)
- Inability to mobilize elbow within 21 days of injury
- Bilateral elbow injury
- Concomitant musculoskeletal or visceral injuries preventing post-operative elbow therapy
- Oral hypoglycemic medications
- History of epilepsy
- Lactose intolerance
- Language or Cognitive difficulties preventing reliable completion of questionnaires
- Females who are pregnant or breast feeding
- Females of reproductive age or males unwilling to use 2 effective methods of contraception
- Severe renal impairment
- Severe hepatic impairment
- Prior elbow injury or operation
- Total elbow replacement planned for treatment of injury
- Unlikely to maintain follow up (no fixed address, plans to move out of town in the next year, states unable to comply with protocol)
- Unwilling or unable to provide written informed consent for trial participation
Where it is running
- 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
Full record on ClinicalTrials.gov
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