PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2 (NCT03582176) | Clinical Trial Compass
CompletedPhase 3
PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
United States, Canada395 participantsStarted 2019-04-26
Plain-language 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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.