E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with osteoarthritis undergoing elective primary single hip arthroplasty |
|
MedDRA Classification |
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 test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients. |
|
E.2.2 | Secondary objectives of the trial |
To determine the CSF (cerebrospinal fluid), plasma and tissue pharmacokinetics of orally administered etoricoxib. To correlate the prostaglandin and cytokine response to clinical outcome parameters after hip arthroplasty.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Subject undergoing elective primary single hip arthroplasty • Subject diagnosed with Osteoarthritis / arthrosis • Age 55 - 80 • Subject has not taken non-steroidal anti-inflammatory drugs within 4 of their half life times prior to enrollment • Subject capable of understanding and cooperating with the requirements of the study |
|
E.4 | Principal exclusion criteria |
• Patients with renal insufficiency (serum creatinine >1.5 mg/dl) • Recent major trauma or systemic infection (within 3 months) • Use of corticosteroid medication or chronic opioids (within 3 months) • Any other condition likely to affect prostaglandin and cytokine levels • Participation in another clinical study or receipt of an investigational drug within 30 days • Hypersensitivity to any component of the etoricoxib and/or placebo tablets • Uncontrolled hypertension defined as systolic blood pressure >160 mm Hg and diastolic pressure >90 mm Hg at rest after two repeated measurements • Congestive heart failure (NYHA II-IV) • Cerebrovascular disease • Established ischemic heart disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty) • Patients with any kind or severity of cirrhosis of the liver or cholestasis or elevated liver function enzymes (ALT or AST 3 fold) as a sign of clinical significant liver malfunction (corresponds to any Child-Pugh-Score ≥5) • Patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) • Pregnancy and lactation • Patients with active peptic ulcerations or active gastro-intestinal (GI) bleeding, • Inflammatory bowel disease • Recent history (within the last year) of alcohol or other substance abuse • An employee of the sponsor or study site • Any neurological syndrome or any other condition leading to contra-indication to spinal anesthesia
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of inflammatory mediators in CSF (cerebrospinal fluid), plasma and tissue (hip darin) after orally administered etoricoxib. Decreased Pain Scores at rest and passive movement of the operated hip and/or reduced consumption of other pain medication after etoricoxib administration.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |