E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Moderate to severe acute postoperative pain | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10054711 | |
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 | The objective of the present study is to generate first data on the safety and efficacy of two different doses of Neramexane mesylate as prophylactic treatment and co-analgesic to opioids in moderate to severe postoperative pain. | |
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | Male or female patients between 18 and 70 years of age at baseline Planned surgery for arthroscopic unilateral anterior cruciate ligament repair using patellar or hamstring autograft technique Traumatic lesion of the anterior cruciate ligament at least 1 month prior to surgery Planned patient controlled analgesia with application of opioids during the first 48 postoperative hours ASA class I or II Planned general anaesthesia following a standardised procedure using sufentanil, thiopental, midazolam, and atracurium, supplemented by halothane/nitrous oxide. Signed Informed Consent Patient is capable to understand the nature of the study and the procedures to be followed including use of PCA Patient is expected to comply with the scheduled visits and dosing scheme For further details please refer to Clinical Trial Protocol MRZ 92579-0404/1, chapter 9.3.1. | |
E.4 | Principal exclusion criteria | Planned intra-articular administration of analgesics or local anaesthetics during surgery History of chronic pain with chronic use of analgesics during the last 6 months Planned use of any analgesics within 48 hours prior to surgery Patients with systemic and/or serious coexisting diseases, such as malignancy (other than excised basal cell carcinoma), or any clinically significant haematological, endocrine (other than euthyroid struma or diabetes sufficiently treated with oral antidiabetics), cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal or neurological (including any form of epilepsy) disease Patients with clinical relevant abnormal ECG findings Potassium ≥ 5.6 mmol/l Patients with systolic blood pressure greater than 160 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 100 mm Hg or less than 50 mm Hg at the screening or baseline visit with or without stable antihypertensive medication Patients with orthostatic dysregulation Patients with known allergy, hypersensitivity, or intolerance to Neramexane, amantadine, ketamine, or memantine Women who are pregnant or breast feeding For further details please refer to Clinical Trial Protocol MRZ 92579-0404/1, chapter 9.3.2. | |
E.5 End points |
E.5.1 | Primary end point(s) | Total (cumulative) opioid consumption during the first 24 postoperative hours | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description | sequential dose escalating | |
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 | 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |