Recruitment

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

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
Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
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
Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
Pregnant and breastfeeding women
History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Patients with bleeding diathesis or on therapy with anticoagulants
Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
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
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

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

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
Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
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
Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
Pregnant and breastfeeding women
History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Patients with bleeding diathesis or on therapy with anticoagulants
Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
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
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

Locations

Firenze, Tuscany, 50139
Cona, 44124
Englewood, Colorado, 80110
Draper, Utah, 84020
Uherske Hradiste, 686 01
...
Firenze, Tuscany, 50139
Cona, 44124
Englewood, Colorado, 80110
Draper, Utah, 84020
Uherske Hradiste, 686 01
Deland, Florida, 32720
Columbus, Ohio, 43212
Prague, 128 50
Milano, 20157
Verona, 37134
Berlin, 1262
Brno, 638 00
Frankfurt, 60596
Magenta, 20013
Altoona, Pennsylvania, 16602
Columbus, Ohio, 43213
Leipzig, 04103
Austin, Texas, 78745
Bochum, 44787
Spokane, Washington, 99218
Hamburg, 22143
Lecce, 73016
Tucson, Arizona, 85712
Leipzig, 04107
Perugia, 06122

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