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PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2

NCT03582176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2025-12-04

No results posted yet for this 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

  • Elbow Fracture
  • Elbow Injury
  • Elbow Dislocation

Interventions

DRUG

Lactose Placebo

One capsule by mouth twice per day

DRUG

Ketotifen Fumarate 2mg

2 mg tablets (over-encapsulated into one capsule) by mouth twice per day

DRUG

Ketotifen Fumarate 5mg

5 mg tablets (over-encapsulated into one capsule) by mouth twice per day

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Calgary

    lead OTHER

Principal Investigators

  • Kevin A Hildebrand, MD, FRCSC · University of Calgary and Alberta Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2024-09-29
Completion
2024-12-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582176 on ClinicalTrials.gov