E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018407 |
E.1.2 | Term | Glucocorticoids normal |
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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 investigate the added effect of an intramuscular gluteal corticosteroid injection on pain symptoms in patients with hip OA, not responding satisfactory to the usual pain medication (acetaminophen or NSAID) at short term (2 weeks). |
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E.2.2 | Secondary objectives of the trial |
- What is the effect on pain reduction of an IM injection with 40 mg triamcinolone acetate versus saline water in hip OA patients at other time points of follow-up (4, 6, 12 weeks)? - What is the effect on functional disability, mobility, patients’ global assessment with respect to perceived improvement from an IM injection with 40 mg triamcinolone acetate versus saline water in hip OA patients at all time points of follow-up? - What is the response rate measured with the OARSI/OMERACT responder criteria of an IM injection with 40 mg triamcinolone acetate versus saline water in hip OA patients at all time points of follow-up? - What is the percentage of side effects of an IM injection with 40 mg triamcinolone acetate versus saline water in hip OA patients at all time points of follow-up? - Is there a difference between the primary effects in the two settings (primary care and secondary care)?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria will be 1. a diagnosis of OA of the hip according to the clinical ACR criteria, including radiologic evidence of OA (Kellgren-Lawrence (K-L) score ge 2) 2. Age > 40 years 3. Symptomatic disease for at least 6 months prior to enrolment 4. Persistent pain despite receiving optimal doses of normal pain medication (acetaminophen (3 gr/day) and/or a NSAID) for at least 3 weeks. Pain severity (in rest or on walking) defined as a minimum score of 3 on NRS (0-10 range) |
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E.4 | Principal exclusion criteria |
The exclusion criteria include local or systemic infection precluding injection, diabetes mellitus, systemic arthritis, allergy to corticosteroid agent, use of oral corticosteroids, coagulopathy, anticoagulant therapy (cumarine type), peptic ulcer, previous IA steroid injection into the index hip the past 6 months, radiologic signs of osteonecrosis, pregnancy, participation in other medical trials, and on the waiting list for a total hip arthroplasty. |
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E.5 End points |
E.5.1 | Primary end point(s) |
What is the effect on pain reduction measured with the WOMAC pain scale and a NRS pain scale for pain in rest and for pain at walking of an IM injection in the upper gluteal region with 40 mg triamcinolone acetate versus saline water in hip OA patients at short-term follow-up (2 weeks)? |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | 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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The trial will end after 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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |