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NCT03582176 · ClinicalTrials.gov registry record · Phase 3

PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2

A Phase 3 study of Elbow Dislocation and Elbow Injury, sponsored by University of Calgary.

Completed
Registry status
Phase 3
Development phase
395
Enrollment target
15
Study locations

NCT03582176 is a Phase 3 study of Elbow Dislocation and Elbow Injury that has completed, run by University of Calgary. The registered enrollment target is 395 participants. The trial reports 15 study locations across 7 states.

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The verdict

NCT03582176, a Phase 3 study of Elbow Dislocation and Elbow Injury, has completed, sponsored by University of Calgary.

COMPLETED
Registry status
Phase 3
Development phase
395 participants
Enrollment target
15
Study locations

Study 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.

Interventions

  • DRUG Lactose Placebo
  • DRUG Ketotifen Fumarate 2mg
  • DRUG Ketotifen Fumarate 5mg

Study Locations (15)

Ontario

  • St. Joseph's Health Care London - London
  • The Ottawa General Hospital - Ottawa
  • The Ottawa Civic Hospital - Ottawa
  • Sunnybrook Health Sciences Centre - Toronto
  • St. Michael's Hospital - Toronto

Alberta

  • Peter Lougheed Centre - Calgary
  • Foothills Medical Centre - Calgary
  • South Health Campus - Calgary
  • Sturgeon Community Hospital - St. Albert

British Columbia

  • Royal Columbia Hospital - New Westminster
  • St. Paul's Hospital - Vancouver

Maryland

  • University of Maryland Medical Centre - Baltimore

North Carolina

  • Carolinas Medical Center - Charlotte

Vermont

  • University of Vermont Medical Center - Burlington

Nova Scotia

  • Queen Elizabeth II Health Sciences Centre - Halifax

Trial Details

FieldValue
Enrollment Target 395 participants
Start Date 2019-04-26
Est. Completion 2024-12-17
Phase Phase 3

Sponsor

University of Calgary

11 total trials

What the Registry Record Tells You About NCT03582176

The ClinicalTrials.gov registry entry for NCT03582176 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 395 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Calgary, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Elbow Dislocation appearing as the primary indexed condition, and to 3 interventions - of which Lactose Placebo is the first listed.

NCT03582176 reports 15 study locations spanning 7 distinct geographic areas - top geographies include Ontario, Alberta, British Columbia.

Frequently Asked Questions

What is clinical trial NCT03582176 about?

NCT03582176 is a clinical study titled "PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2". 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 moti...

What is the current status of trial NCT03582176?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2019-04-26. Estimated completion is 2024-12-17.

What conditions does trial NCT03582176 study?

This clinical trial studies the following conditions: Elbow Dislocation, Elbow Injury, Elbow Fracture.

What interventions are being tested in trial NCT03582176?

The interventions under investigation include: Lactose Placebo (DRUG), Ketotifen Fumarate 2mg (DRUG), Ketotifen Fumarate 5mg (DRUG).

Who is sponsoring clinical trial NCT03582176?

This trial is sponsored by University of Calgary, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03582176 being conducted?

This trial has 15 study locations across Maryland, North Carolina, Vermont, Alberta, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.