Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 400
Inclusion Criteria
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
Exclusion Criteria
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- ...
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- Pregnant and breastfeeding women
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
- History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
- Patients with bleeding diathesis or on therapy with anticoagulants
- Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 80 years
- Gender
- Both males and females
Inclusion Criteria
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
Exclusion Criteria
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- ...
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- Pregnant and breastfeeding women
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
- History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
- Patients with bleeding diathesis or on therapy with anticoagulants
- Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
Tracking Information
- NCT #
- NCT02205814
- Collaborators
- Not Provided
- Investigators
- Study Chair: Karel Pavelka, Professor Institute of Rheumatology, Charles University Faculty Hospital, Na Slupi 4, 128 50 Prague 2, Czech Republic