A placebo-controlled study assessing the tolerability and plasma concentrations of ascending doses of fasitibant in patients with osteoarthritis of the knee.

• Conditions: Ostoarthritis of the knee; MedDRA version: 14.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005254-53-DE
• Lead Sponsor: Menarini Ricerche S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-14
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Written informed consent.
2.Male or female patients = 30 years old and a BMI < 30 kg/m².
3.Women of childbearing potential are eligible to participate in the study if their pregnancy test is negative at screening, they are not nursing, and they use an effective method of contraception.
4. Symptomatic primary or secondary knee osteoarthritis for which IA treatment is indicated.
5. Pain score >5 points assigned to the index knee at WOMAC NR 3.1-A1.
6. Pain score >12 points assigned to the index knee at WOMAC NR 3.1 A subscore. 7. Pain in the index knee on at least 50% of the days in the month preceding the screening.
8. Minimum flexion of 90 degrees in both knees.
9. Ability to perform the 15 m walk test without the support of crutches or other assistive devices.
10. Willingness to discontinue all pain or OA medication.
11. Willingness to refrain from paracetamol use 48 hours prior to each study visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Inability to personally provide written informed consent.
2. Inability to understand or collaborate throughout the study.
3. Patients who participated in another clinical trial within 30 days prior randomisation.
4. Patients with severe OA of the knee.
5. Knee condition representing an indication for surgery .
6. Inflammatory or crystal arthropathies.
7. Patients with acute fractures, severe loss of bone density, bone necrosis.
8. Patients with isolated patella-femoral syndrome or chondromalacia.
9. Patients with OA predominant in the lateral compartment.
10. Patients with any other clinically significant and unstable disease or condition interfering with the evaluation of the safety of study treatment.
11. Major injury or surgery to the index knee within the previous 12 months prior to screening.
12. Severe hip OA ipsilateral to index knee.
13. Any pain >3 points in the numerical rating (NR) scale (0-10) that could interfere with the assessment of the index knee pain.
14. Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation.
15. Use of systemic or topical corticosteroids >10 mg prednisolone equivalent.
16. Use of any pain or OA medication.
17. Any acute or newly diagnosed disease/condition requiring treatment.
18. Any unstable chronic disease/condition requiring treatment modification.
19. History of hypersensitivity to drugs including paracetamol.
20. Patient with known hypersensitivity to hyaluronate preparations.
21. Patients with any of the following
a) clinically relevant cardiovascular, pulmonary, gastrointestinal, haematological, neurologic-psychiatric or infectious diseases.
b) clinically relevant abnormal safety laboratory test result and/or clinically relevant abnormalities in vital signs and/or ECG parameters at screening (Visit 1) and/or prior to dose administration (Visit 2).
22. Patients with liver disease
23. Patients with moderate or severe renal insufficiency (Creatinie Clearence [CrCl according to Cockgroft-Gault formula] < 60 mL/min).
24. Any sign of significant inflammation or infection.
25. Any skin disorder or infection overlying the index knee.
26. Previous infection of the index knee.
27. Any IA or local peri-articular punction, injection, or surgery to the index knee during the 3 months prior to screening.
28. Patients with bleeding diathesis or on therapy with anticoagulants.
29. Significant peri-articular calcification.
30. Previous ligament reconstruction at the index knee.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified