E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Morphine requirements after knee replacement surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 achieve adequate postoperative pain relief in patients after knee replacement surgery, a higher accumulative amount of intravenous morphine is needed after blockade of peripheral opioid receptors by active treatment with methylnaltrexone compared to inactive treatment with placebo. |
|
E.2.2 | Secondary objectives of the trial |
To test the impact of active vs. inactive treatment on pain scores at rest and movement, signs of withdrawal, effects on vital parameters and adverse events, bowel dysfunction, inflammation, sex specific variations |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients undergoing knee replacement surgery under total anaesthesia, informed consent to participate in the clinical study, capable to give written informed consent, 18-83 years |
|
E.4 | Principal exclusion criteria |
Chronic opioid treatment, Chronic pain with psychiatric/psychosomatic component, Abuse of drugs or alcohol, psychiatric/mental disease, Rheumatoid arthritis with chronic steroid or opioid medication, Chronic pulmonary disease with systemic steroid medication; pulmonary hypertension, Severe heart failure (NYHA>III); peripheral vascular disease, Diabetes mellitus with peripheral polyneuropathy (sensory deficit), ulcers/necrosis/infections, Paralysis, neurological deficits, Gastrointestinal dysfunction/inflammation, ileus, Acute infections, cancer, HIV, hepatitis, Pregnancy; emergency surgery, Intolerance reactions to methylnaltrexone, Participation in other trials, Surgery longer than 3 hours |
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E.5 End points |
E.5.1 | Primary end point(s) |
Accumulative amount of intravenous morphine over the first 8 hours after surgery. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First 12 hours hourly and after 24 hours |
|
E.5.2 | Secondary end point(s) |
Impact of verum vs. placebo treatment on pain scores at rest and movement, signs of withdrawal, effects on vital signs, adverse Events, bowel dysfunction, inflammation, sex specific variation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
First 12 hours hourly and after 24 hours |
|
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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |