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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 24 weeks, 52 weeks

Awards & highlights

PERK2 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.Check my eligibility

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.See study design

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.

PERK2 Trial 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.

PERK2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 24 weeks, 52 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Elbow Extension-Flexion Arc of Motion

Secondary outcome measures

Patient Reported Outcome Measures

Radiographs

Range of Motion at other time points

PERK2 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

861 Previous Clinical Trials

226,799 Total Patients Enrolled

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,339 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please detail the potential side effects of Ketotifen Fumarate - 5mg?

"Ketotifen Fumarate - 5mg is considered safe."

Answered by AI

Is this clinical trial offered at a large number of hospitals in town?

"At the time of this writing, patients are being accepted at 17 different locations across Canada. These include Peter Lougheed Centre in Calgary, Alberta, Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, and St. Michael's Hospital in Toronto, Ontario."

Answered by AI

What medical conditions Ketotifen Fumarate - 5mg help to alleviate?

"Ketotifen Fumarate - 5mg can be used to treat seasonal allergic conjunctivitis, as well as other conditions such as allergic conjunctivitis, eye conditions, and asthma."

Answered by AI

Does this experiment prohibit those aged 65 and over from participating?

"Eligibility for this study includes patients aged 18 to 95. In contrast, there are 29 active trials for minors and 47 for seniors."

Answered by AI

Does this research study have any prerequisites for participants?

"This study is looking for 702 patients aged 18-95 who have contracture and meet the following additional criteria: AO/OTA type 13 distal humerus and/or proximal ulna and/or proximal radius fractures and/or elbow dislocations (open fractures with or without nerve injury may be included), age ≥ 18 years old, skeletally mature with no growth plates in the elbow, operative treatment of the elbow fracture or dislocation, injury ≤ 7 days, negative urine or blood serum pregnancy test."

Answered by AI

Are new enrollees still being accepted for this research project?

"That is accurate. The public information available on clinicaltrials.gov reveals that this clinical trial is looking for 702 patients and is being hosted at 16 different sites. The first posting was on 2019-04-26, with the most recent update being on 2022-10-31."

Answered by AI

Does Ketotifen Fumarate - 5mg have a history of being tested in other medical studies?

"Since 2015, when Ketotifen Fumarate - 5mg was first studied at The Children's Mercy Hospital, there have been 18 completed clinical trials. There are 3 live studies currently being conducted, a large number of which are based in Calgary, Alberta."

Answered by AI

How many patients are in this testing group?

"In order to move forward with this clinical trial, 702 individuals who meet the pre-determined requirements must enroll. Those that choose to participate will be able to do so at the Peter Lougheed Centre in Calgary, Alberta or the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia."

Answered by AI