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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

NCT02845271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-04-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

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 NCT02845271 on ClinicalTrials.gov