Study with random distribution of treatments (fasitibant and placebo given in combination with sodium hyaluronate), where neither the investigator nor the patients know the treatment taken, to evaluate efficacy of the drug when injected into the knee joint in the patients with osteoarthritis of the knee.

• Conditions: Symptomatic osteoarthritis (OA) of the knee.; MedDRA version: 17.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004435-40-CZ
• Lead Sponsor: Menarini Ricerche Spa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-08
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.Properly executed written informed consent.
2.Male or female patients 40-80 years old and with a BMI < 30 kg/m².
3.Mentally competent and compliant to undergo all visits and procedures scheduled in the study, including questionnaires/ symptoms reporting.
4.Women of childbearing potential [i.e. not postmenopausal (postmenopausal defined as 52 years or older and amenorrhoeic for at least 2 years at Screening); not surgically sterile (i.e. have had a hysterectomy or bilateral oophorectomy tubal ligation), or otherwise be incapable of pregnancy] and sexually active are eligible if they use a double-barrier method of contraception supplemented with the use of a spermicide for at least 30 days after treatment administration. Since a potential interaction between IMP metabolism and hormonal contraceptives cannot be fully excluded, the use of hormonal contraception (oral, injections or implants) is not regarded as highly effective method and it is not a sufficient method for contraception in this study. True sexual abstinence is considered an acceptable method of contraception.
5.Symptomatic primary knee osteoarthritis (American College of Rheumatology [ACR] criteria) since = 3 months prior to screening, with documented Kellgren Lawrence Grade 2 to 3 radiological severity based on X-ray not older than 6 months, for which an IA treatment is indicated.
6.WOMAC VA 3.1 A subscore (total pain) at the target knee = 200 mm and <400 mm out of the 500 mm total score on visual analogue scale (VAS).
7.WOMAC VA 3.1 A1 subscore (pain while walking on a flat surface) at the target knee = 40 mm and < 80 mm on a 100 mm VAS.
8.WOMAC VA 3.1 A subscore (total pain) at the contralateral knee < 150 mm out of the 500 mm total score on VAS.
9.Knee pain of moderate to severe intensity along the previous 4 weeks, even if treated with chronic doses of non steroidal antinflammatory drugs or other analgesics.
10.Minimum flexion of 90 degrees in both knees.
11.Ability to perform the 15-meter walk test without the support of crutches or other assistive devices.
12.Willingness to discontinue all analgesics or other OA medications and OA dietary supplements (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs], cyclooxygenase-2 [COX-2] inhibitors, antidepressive OA agents and chondroitinsulfate) prior to randomisation and for the entire course of the study, with a minimum wash-out period corresponding to five half-lives of drug.
13.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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1.Inability to personally provide written informed.
2.Inability to understand or collaborate with study procedures and requirements, including answering to the study questionnaire/symptoms reporting.
3.Patients who participated in another clinical trial within 30 days (90 days in case of OA trial) prior to screening.
4.Patients with Kellgren Lawrence Grade 1 or Grade 4 OA of the knee.
5.Knee condition representing on Investigator’s judgment an indication for surgery.
6.OA secondary to inflammatory/autoimmune forms of arthritis, septic arthritis, or genetic diseases, which have a distinct impact on the outcome.
7.Patients with acute fractures, severe loss of bone density, history of aseptic necrosis, isolated patella-femoral syndrome, or joint replacement in the affected knee.
8.Patients with OA predominant in the lateral compartment, or any significant valgus deformity.
9.Patients who -as per Investigator’s judgment- have any clinically significant or unstable disease or condition interfering with the evaluation of the safety and efficacy of study treatment along the study period.
10.History of symptomatic severe hip OA or painful hip prosthesis.
11.Major injury (including ligament sprains or muscle/tendon strains > grade 2 and meniscal tears > grade 2) or major surgery (including arthroscopic interventions on cartilage or meniscus) to the index knee.
12.Any musculoskeletal pain > 30 mm on a 100 mm VAS that could interfere with the index knee pain assessment (e.g. local or radiating pain in any part of the lower extremities).
13.Clinically significant venous or lymphatic stasis in the relevant limb.
14.Acupuncture and physiotherapy in the last 4 weeks prior to randomisation, or likely to start during the course of the study.
15.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.
16.Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs during 30 days prior to randomisation, or likely to be used during the course of the study.
17.Use of any pain or OA medication and OA dietary supplements (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive OA agents and chondroitin sulfate), including topical treatments, within a minimum of 5 times their half-life prior to randomisation and during the course of the study.
18.Viscosupplementation (intra-articular injection of hyaluronic acid) to the target knee administered < 6 months prior to randomisation and/or scheduled during the course of the study other than as specified in the protocol.
19.History of hypersensitivity/allergy to drugs including paracetamol and disinfectants (antimicrobial soaps and /or povidone-iodine solution).
20.Patients with known hypersensitivity to hyaluronate preparations or allergy to avian proteins, feathers, and eggs.
21.Use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors during the 4 weeks prior to Randomisation and the overall study duration.
22.Patients with any of the following:
a.clinically relevant cardiovascular, pulmonary, gastro-intestinal, haematological, neurologic, psychiatric, or infectious diseases, or unstable metabolic diseases, 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;
b.clinically relevant (according

Study & Design

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