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
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
Exclusion Criteria
- Patients with bleeding diathesis or on therapy with anticoagulants
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- 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
- ...
- Patients with bleeding diathesis or on therapy with anticoagulants
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- 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
- 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 any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Pregnant and breastfeeding women
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
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
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
Exclusion Criteria
- Patients with bleeding diathesis or on therapy with anticoagulants
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- 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
- ...
- Patients with bleeding diathesis or on therapy with anticoagulants
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- 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
- 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 any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Pregnant and breastfeeding women
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
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
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