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COMPLETED Phase 3

PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2

NCT03582176 · View on ClinicalTrials.gov ↗

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

64 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03582176

The ClinicalTrials.gov registry entry for NCT03582176 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03582176 reports 15 study locations spanning 7 distinct geographic areas — top geographies include Ontario, Alberta, British Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03582176?

The interventions under investigation include: Lactose Placebo (DRUG), Ketotifen Fumarate 2mg (DRUG), Ketotifen Fumarate 5mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03582176?

This trial is sponsored by University of Calgary, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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