E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Knee osteoarthritis Hip osteoarthritis |
Polven nivelrikko Lonkan nivelrikko |
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E.1.1.1 | Medical condition in easily understood language |
Knee osteoarthritis Hip osteoarthritis |
Polven nivelrikko Lonkan nivelrikko |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020108 |
E.1.2 | Term | Hips osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
We aim to measure concentration of dexmedetomidine in plasma after intranasal administration in supine, anesthetized patients. |
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E.2.2 | Secondary objectives of the trial |
Adrenaline and noradrenaline plasma concentrations |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient is scheduled for elective unilateral total knee arthroplasty (TKA) or hip arthroplasty (THA) under general anesthesia 2. Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel) 3. Age between 35 and 80 years 4. Weight between 50 and 100 kg 5. ASA (American Society of Anesthesiologists) status 1-3 6. Written informed consent from the patient
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E.4 | Principal exclusion criteria |
1. A previous history of intolerance to the study drug or related compounds and additives 2. Disease or condition affecting patient’s ability to give written informed consent 3. Existing or recent significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug 4. History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree AV-block, pacemaker) 5. Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine 6. Participation in any other study concomitantly or within one month prior to the entry into this study 7. Clinically significant abnormal findings in physical examination or laboratory screening 8. Use of drugs or natural products known to cause enzyme induction or inhibition 9. Pregnancy or breastfeeding 10. Spinal anesthesia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quantity of dexmedetomidine in plasma after intranasal administration |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h. |
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E.5.2 | Secondary end point(s) |
Adrenaline and noradrenaline plasma concentrations |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |