E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post operative pain after diagnostic or therapeutic knee arthroscopy |
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E.1.1.1 | Medical condition in easily understood language |
Pain in knee after arthroscopy |
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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 | 16.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10023213 |
E.1.2 | Term | Joint disorders |
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 |
To examine the postoperative pain relieving effects of anakinra compared to placebo |
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E.2.2 | Secondary objectives of the trial |
Biomarkers of inflammation and pain |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Otherwise healthy patients between 18 and 70 years undergoing diagnostic or therapeutic knee arthroscopy. |
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E.4 | Principal exclusion criteria |
1. Pregnancy or lactation 2. Established osteoarthritis or synovitis 3. Known intolerance to anakinra 4. Kidney failure (Creatinine clearance <30ml/min) 5. History of frequent infectious diseases or immunodeficiency 6. Heart failure 7. History of drug –or alcohol abuse 8. Participation in other synchronous clinical trials 9. Perioperative steroidtreatment, perioperative acetaminophen (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs). 10. Use of tourniquet for bloodless field 11. Strong preoperative pain 12. Intolerable postoperative pain (VRS=4)
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain is measured postoperatively using the verbal rating scale (VRS 0-4). Patients with VRS 2 or 3 are included in the intervention group receiving either active drug or placebo. Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain is measured as soon as possible postoperatively using the verbal rating scale (VRS 0-4). Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. |
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E.5.2 | Secondary end point(s) |
The use of morphine is registered throughout the observation period |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | |