Osteoarthritis of the Knee

Before the first screening visit, there is a pre-Screening Telephone Call or email interview, the Screening Period of at least 14 days up to 3 weeks will consist of two visits for the assessment of eligibility including radiographic evaluation of the target knee joint space, all screening visits and double-blind treatment visit (week 2, 4, 8, 12 visits) are show in Study Flow Chart of Double-blind Period, and the open label period will be started from the Week 12 visit (see Table 2). All subjects treated with active drug or placebo complete the 12-week double-blind study will enter this Open-label study and will be treated with active drug, X0002.

X0002

A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Knee

A Phase 3, Multicenter, 12-Week, Double-Blind and 40-Week Open Label Study to Evaluate the Efficacy and Safety of X0002 Spray in Relief of the Signs and Symptoms of Subjects With Osteoarthritis of the Knee

To evaluate the effect of X0002 spray compared to placebo for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at Week 12.

To evaluate the effect of X0002 spray for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at 2, 4, 8, 22, 32, 42, and 52 weeks of treatment.

To evaluate the effect of X0002 spray for the relief of joint stiffness in subjects with OA of the knee as measured by the WOMAC stiffness subscale score in the target knee.

To evaluate the effect of X0002 spray on difficulty performing daily activities in subjects with OA of the knee as measured by the WOMAC functional ability subscale score in the target knee.

To evaluate the effect of X0002 spray in subjects with OA of the knee as measured by the overall WOMAC (VAS) score in the target knee.

To evaluate the efficacy of X0002 spray in change of radiographic joint space (at standardized locations in the medial and lateral compartments) of the target knee of subjects with osteoarthritis (OA) of the knee as measured by X-ray.

To evaluate the efficacy of X0002 spray in changes of MOAKS28 (see Appendix 5) scale of subjects with osteoarthritis (OA) of the knee as measured by quantitative magnetic resonance imaging (3D qMRI) of femur, tibia and patella periarticular bone area.

To evaluate the efficacy of X0002 spray in change of cartilage thickness (at standardized locations in the femur, tibia and patella compartments) of subjects with osteoarthritis (OA) of the knee as measured by quantitative magnetic resonance imaging (3D qMRI) of femur, tibia and patella periarticular bone area.

Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.

To assess change from Baseline in the amount of rescue medication (acetaminophen) consumed per day for target knee pain in subjects with OA of the knee.

Techfields Pharma Co. Ltd

Fifty consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients will be recruited between January 2017 and January 2018 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo, Italy.

Fifty sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as first control group. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo, Italy.

Fifty sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as second control group. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo.

Non-celiac Wheat Sensitivity

The investigators will evaluate the prevalence of fibromyalgia-like joint/muscle pain and the possible ultrasonographical alterations (i.e. synovitis) of hands and feet joints in NCWS patient at baseline (i.e. at the moment of diagnosis) and after a gluten free diet period of almost 6 months.

Gluten free diet

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Department of Internal Medicine, University Hospital of Palermo

Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients

Prevalence of fibromyalgia-like joint/muscle pain in NCWS patient using an ad hoc questionnaire and orientated clinical examination (tenders and triggers point evaluation)

Hands and feet joints ultrasonography alterations in NCWS patients.

Modification of fibromyalgia-like joint/muscle pain, by visual analogic scale, in NCWS patients after a gluten free diet period of almost 6 months.

Modifications of hands and feet joints ultrasonography alterations in NCWS patients after a gluten free diet period of almost 6 months.

synovitis/galvos skausmas

A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Knee

Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients

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