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Antihistamine

Ketotifen for Joint Contracture (PERK2 Trial)

Phase 3
Waitlist Available
Led By Kevin A Hildebrand, MD, FRCSC
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
History of epilepsy
Females who are pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 24 weeks, 52 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether ketotifen can prevent post-traumatic contractures (reduced range of motion due to scarring after an injury).

Who is the study for?
Adults over 18 with recent elbow injuries (fractures or dislocations) suitable for surgery, without prior elbow issues, severe kidney/liver problems, lactose intolerance, epilepsy, diabetes on oral medication, or pregnancy. Participants must be willing to use contraception and commit to follow-up visits.
What is being tested?
The PERK 2 trial is testing the effectiveness of Ketotifen Fumarate at two different doses (2mg and 5mg) versus a placebo in improving movement range in the elbow after injury. It's a Phase III study where patients are randomly assigned to one of three groups and treated for six weeks.
What are the potential side effects?
While not specified here, common side effects of Ketotifen include drowsiness, dry mouth, increased appetite leading to weight gain; less commonly it can cause mood changes or trouble sleeping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fracture or dislocation in my elbow area.
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I had surgery for an elbow fracture or dislocation.
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I am over 18 and my elbow bones have fully developed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of epilepsy.
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I am not pregnant or breastfeeding.
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I have severe kidney problems.
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I have arthritis in my elbow.
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I have injuries that stop me from doing elbow therapy after surgery.
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I am taking oral medication for diabetes.
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I have severe liver problems.
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I have had a previous elbow injury or surgery.
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I am scheduled for a total elbow replacement due to an injury.
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I have injuries to both of my elbows.
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I have a stiff elbow that doesn't fully straighten.
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I am using two effective birth control methods or am not of reproductive age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 24 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 24 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Elbow Extension-Flexion Arc of Motion
Secondary study objectives
Patient Reported Outcome Measures
Radiographs
Range of Motion at other time points

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Ketotifen Fumarate - 5mgActive Control2 Interventions
Ketotifen Fumarate 5 mg by mouth twice per day
Group II: Ketotifen Fumarate - 2mgActive Control2 Interventions
Ketotifen Fumarate 2 mg by mouth twice per day
Group III: Lactose PlaceboPlacebo Group1 Intervention
Lactose Placebo by mouth twice per day

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
913 Previous Clinical Trials
333,911 Total Patients Enrolled
University of CalgaryLead Sponsor
810 Previous Clinical Trials
885,899 Total Patients Enrolled
Kevin A Hildebrand, MD, FRCSCPrincipal InvestigatorUniversity of Calgary and Alberta Health Services

Media Library

Ketotifen Fumarate (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT03582176 — Phase 3
Elbow Fractures Research Study Groups: Ketotifen Fumarate - 5mg, Lactose Placebo, Ketotifen Fumarate - 2mg
Elbow Fractures Clinical Trial 2023: Ketotifen Fumarate Highlights & Side Effects. Trial Name: NCT03582176 — Phase 3
Ketotifen Fumarate (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03582176 — Phase 3
~60 spots leftby Dec 2025
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