PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2

Phase 3 Completed 395 enrolled University of Calgary United States Department of Defense · collab

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2019-04-26
Primary completion: 2024-09-29
Completion: 2024-12-17

Publications

Ademola A, Hildebrand KA, Schneider PS, Mohtadi NGH, White NJ, Bosse MJ, Garven A, Walker REA, Sajobi TT. PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) - protocol for a multicenter randomized clinical trial. BMC Musculoskelet Disord. 2020 Feb 24;21(1):123. doi: 10.1186/s12891-020-3139-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ketotifen	Small molecule	2 mg	Oral
Comparator	Ketotifen	Small molecule	5 mg	Oral

Indications

No indication recorded.