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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2024-12-17 |
| Phase | Phase 3 |
Interested in This Trial?
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, 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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