Moderate to severe pain associated with osteoarthritis of the knee MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Code: RTX-GRT7039
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: resiniferatoxin
CAS Number: 57444-62-9
Other descriptive name: RTX, GRT1076857
Concentration
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • = 18 years of age at the screening visit. • Body Mass Index (BMI) = 40.0 kg/m2. • Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III. • Moderate to severe osteoarthritis at baseline. • Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC). • The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient’s pain treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: • The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within 3 months. • The subject had an injection of platelet-rich plasma into the index knee within 6 months. • The subject applied topical capsaicin on the index knee within 3 months. • Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis. • Other conditions that could confound discrimination of pain assessment in the index knee. • Clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of the trial. • History of severe allergic or anaphylactic reactions. • History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1) Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score in the index knee.;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 5.;Main Objective: Demonstrate the analgesic efficacy of intra-articular RTX-GRT7039 compared with placebo.;Secondary Objective: • Demonstrate the analgesic efficacy of intra-articular RTX-GRT7039 compared with placebo. • Demonstrate the efficacy of intra-articular RTX-GRT7039 on function compared with placebo. • To assess the safety and tolerability of intra-articular RTX-GRT7039. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in WOMAC pain subscale score in the index knee based on the 11-point numeric rating scale (NRS). 2) Change in WOMAC physical function subscale score. 3) Incidence of treatment-emergent adverse events (TEAEs). Incidence of related TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI]).;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 6. 2) From baseline (assessment at Visit 2) to Visit 5 to Visit 6. 3) From baseline (assessment at Visit 2) to Visit 8 (end of trial). | — |
Countries
Bulgaria, Denmark, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactGrünenthal Trial Information Desk
Grünenthal GmbH
Outcome results
None listed