E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with osteoarthritis of the hip |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048793 |
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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 |
To evaluate the effect of 24-week treatment with Structum® versus placebo on pain at walking in patients suffering from hip osteoarthritis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the degree of the functional improvement after 24-week treatment,
To evaluate the degree of the overall improvement reported by the patient after 24-week treatment,
To evaluate the degree of the improvement according to the investigator judgment after 24-week treatment,
To evaluate the antalgic drug consumption (paracetamol and NSAID) during the 24-week treatment duration,
To evaluate the improvement of the patient quality of life after 24-week treatment,
To evaluate the clinical tolerance. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Aged from 40 to 75 years, - Suffering from osteoarthritis of the hip: - answering to the ACR (American College of Rheumatology) criteria, - evoluting for more than 6 months, - with a pain score to the VAS (Visual Analogical Scale) higher than 40, - with grade II or III of Kellgren and Lawrence classification established from a radiography dated lesser than 6-months, - Unilateral coxalgia at the inclusion. |
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E.4 | Principal exclusion criteria |
- Haemochromatosis, ochronosis or haemophilia, - Paget’s disease, chondromatosis or benign synovioma, - Known symptomatic gonarthrosis homolateral to the hip osteoarthritis, - Non osteoartritic pathology, inflammatory, infectious or metabolic arthritis (rheumatoid polyarthritis, ankylosing spondylitis, abarticular rheumatism), - Symptomatic trochanteric bursitis or acute joint trauma of the target hip, - Target hip, arthroscopy within the previous year, - Hip osteoarthritis or other osteoarthritic pathology invalidating and/or that may need surgery during the study period, - Using or having used NSAID within the past 2 days (including topical treatment near the hip osteoarthritis) or an antalgic drug within the past 12 hours, - Having used treatment with SYSADOA (Symptomatic Slow-Acting Drugs for Osteoarthritis) within the 3 months prior to study start, - Having used corticoids (by systemic or local route near the hip osteoarthritis) within the past month, - Having received an intra-articular injection of corticoids, in the hip within the past 3 months, - Being asthmatic needing regular or intermittent corticoid treatment, - Immunodeficient patients or suffering from disease serious or chronic (cardiac, pulmonary, hepatic, renal, haematological, neoplasic or infectious), - Acute or severe chronic pathology judged by the investigator as serious and incompatible with the study, - History of pathology which, in the judgement of the investigator, puts them “at risk” or is likely to modify their handling of the study results. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main criterion is defined as the mean pain felt during walking: evaluated according to the VAS scale: 0 to 100 after 24-weeks of treatment (comparison between test product (Structum®) and placebo effects). |
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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 | No |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |