Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | COMPLETED | 104 | — | — | Jul 21, 2016 | Sep 13, 2017 | Apr 13, 2022 | 2 | Germany |
| NCT02424942 | First-in-human Study With Ascending Single Intra-articular Doses of GZ389988 in Patients With Painful Osteoarthritis of the Knee | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2015 | Jul 1, 2016 | Aug 17, 2016 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| GZ389988 | EXPERIMENTAL | Single intraarticular injection of GZ389988 in the knee joint |
| Placebo | PLACEBO_COMPARATOR | Single intraarticular injection of placebo for GZ389988 in the knee joint |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | Pharmaceutical form:solvent for parenteral use Route of administration: intraarticular |
| GZ389988 | DRUG | Pharmaceutical form:suspension for injection Route of administration: intraarticular |
| acetaminophen or paracetamol | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| fixed combination of paracetamol + codeine | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| fixed combination of paracetamol + tramadol hydrochloride | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Men or women 40 to 80 years of age. * Diagnosis of primary knee osteoarthritis (OA), based upon the following: * Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), with * X-ray evidence within the la...