Status:
COMPLETED
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
Lead Sponsor:
Menarini Group
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerabili...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
- Viscosupplementation to the target knee administered \< 4 months prior to randomisation and/or scheduled during the course of the study
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- 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
- Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Pregnant and breastfeeding women
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Patients with bleeding diathesis or on therapy with anticoagulants
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT02205814
Start Date
April 1 2014
End Date
January 1 2015
Last Update
November 3 2015
Active Locations (25)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
Colorado Orthopaedic Consultants
Englewood, Colorado, United States, 80110
3
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
4
Radiant Research
Columbus, Ohio, United States, 43212