Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criterias

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 Criterias

Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
Patients with bleeding diathesis or on therapy with anticoagulants
Pregnant and breastfeeding women
...
Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
Patients with bleeding diathesis or on therapy with anticoagulants
Pregnant and breastfeeding women
Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
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
Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
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
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 Criterias

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 Criterias

Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
Patients with bleeding diathesis or on therapy with anticoagulants
Pregnant and breastfeeding women
...
Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
Patients with bleeding diathesis or on therapy with anticoagulants
Pregnant and breastfeeding women
Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
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
Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
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
Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs

Locations

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

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