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Allergy pill may keep elbows moving after break

NCT ID NCT03582176

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tested whether ketotifen, an allergy medicine, can prevent elbow stiffness after a fracture or dislocation. 395 adults took either a low or high dose of ketotifen or a placebo pill twice daily for 6 weeks. The main goal was to see if the drug improved elbow range of motion 12 weeks after starting treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

395 people

The number who actually took part.

Started

Apr 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bone fracture Elbow Fractures Elbow Injuries humerus fracture radius fracture ulna fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elbow dislocation Elbow fracture Elbow injury

Contacts and locations

Locations

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4, Canada

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Royal Columbia Hospital

    New Westminster, British Columbia, V3L 3W7, Canada

  • South Health Campus

    Calgary, Alberta, T3M 1M4, Canada

  • St. Joseph's Health Care London

    London, Ontario, N6A 4V2, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Sturgeon Community Hospital

    St. Albert, Alberta, T8N 6C4, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Civic Hospital

    Ottawa, Ontario, K1Y 4E9, Canada

  • The Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • University of Maryland Medical Centre

    Baltimore, Maryland, 21201, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

More trials for these conditions

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