NCT02845271

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

A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-articular Dose of the TrkA Inhibitor, GZ389988, in Patients With Painful Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Screening will be performed within 21 days of dosing. Following the single dose of study medication, the study period for each patient will be 84 ± 7 days up to the end-of-study visit. Total duration for one patient will be up to 16 weeks (up to the end-of-study visit), not including the long-term observational safety follow-up phone call for 12 additional weeks. The collection of primary endpoint data up to Week 4 for futility analysis is optional. Assuming a possible step-down in dose due to safety/tolerability reasons, the total expected maximum number of included patients could be increased up to a maximum of 182 patients.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	placebo	Pharmaceutical form:solvent for parenteral use Route of administration: intraarticular
DRUG	GZ389988	Pharmaceutical form:suspension for injection Route of administration: intraarticular
DRUG	acetaminophen or paracetamol	Pharmaceutical form: tablet Route of administration: oral
DRUG	fixed combination of paracetamol + codeine	Pharmaceutical form: capsule Route of administration: oral
DRUG	fixed combination of paracetamol + tramadol hydrochloride	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2016-07-21
• Primary completion: 2017-06-28
• Completion: 2017-09-13
• First posted: 2016-07-27
• Last updated: 2022-04-13

Locations

2 sites across 1 country: Germany