E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003416 |
E.1.2 | Term | Arthrosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment (WOMAC pain subscale) in knee OA patients with moderate to severe pain. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include the comparison of other outcomes related to signs and symptoms of knee OA and to compare the safety and tolerability of both treatment groups. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Serum samples collection for the analysis of biomarkers related to synovium inflammation, bone formation and cartilage degradation. |
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E.3 | Principal inclusion criteria |
-Diagnosis of primary OA of the knee according to the ACR criteria
-Patients with OA of radiological stages II or III according to Kellgren and Lawrence
-Patients with moderate-to-severe knee pain: WOMAC pain score > 301 at the Inclusion visit |
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E.4 | Principal exclusion criteria |
-Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget’s disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
-Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure
-Subjects with any significant diseases or conditions, including emotional or psychiatric disorders or substance abuse that, in the opinion of the Investigator, are likely to alter the course of OA or the subject’s ability to complete the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline (mean decrease) in WOMAC Pain subscale after 6 months of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Screening visit, inclusion visit, 30-days follow-up visit, 60-days follow-up visit, 120-days follow-up visit and final visit (180-days). |
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E.5.2 | Secondary end point(s) |
Efficacy outcomes
-Change from baseline (mean decrease) in both WOMAC Stiffness Subscale and Function Subscale after 6 months of treatment.
-Change from baseline (Mean decrease) in pain according to Huskisson’s VAS after 6 months of treatment.
-OARSI set of responder criteria.
-Assessment of the presence or absence of joint swelling and/or effusion.
-Consumption of rescue medication.
-Patient’s global assessment of disease activity.
-Investigator’s global assessment of disease activity.
-Patient’s global assessment of response to therapy.
-Investigator’s global assessment of response to therapy.
-Health status according to EuroQoL-5D.
Safety outcomes
-The tolerability assessment of study treatments will be carried out in accordance with the number of patients who require discontinuation of the study medication because of AE
-Monitoring of the laboratory parameters that will include haematology profile, SR, CRP, liver function test (AST, ALT, bilirubin), renal function test (urea, creatinine, electrolytes), glucose, insulin, partial thromboplastin, total cholesterol, LDL, HDL, triglycerides after a 12-hour fast and urinalyses.
-Additional safety parameters would include the examination of vital signs such as blood pressure and BMI and the physical examination. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Inclusion visit, follow-up visits and final visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial will be the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |