Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee

Phase 2 Completed 104 enrolled Genzyme, a Sanofi Company

RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee. Secondary Objectives: To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients with painful OA of the knee. To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in patients with painful OA of the knee.

Timeline

Start: 2016-07-21
Primary completion: 2017-06-28
Completion: 2017-09-13

Publications

Krupka E, Jiang GL, Jan C. Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study. Osteoarthritis Cartilage. 2019 Nov;27(11):1599-1607. doi: 10.1016/j.joca.2019.05.028. Epub 2019 Jul 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GZ389988	Small molecule	—	Other
Background	Acetaminophen	Small molecule	—	Oral
Background	Codeine	Small molecule	—	Oral
Background	Tramadol	Other / unclassified	—	Oral

Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee

Summary

Timeline

Publications

Drugs

Indications