NCT02845271View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL

Enrollment

104

Participants

Timeline

Start Date

July 21, 2016

Primary Completion Date

June 28, 2017

Study Completion Date

September 13, 2017

Conditions

Osteoarthritis

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"

Trial Locations (2)

14050

Investigational Site Number 276001, Berlin

23538

Investigational Site Number 276002, Lübeck

All Listed Sponsors

lead

Genzyme, a Sanofi Company

INDUSTRY

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 | Biotech Hunter | Biotech Hunter