Moderate to severe acute postoperative pain MedDRA version: 7.1 Level: LLT Classification code 10054711
Conditions
Interventions
Product Name: Neramexane mesylate 25 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Neramexane mesylate
CAS Number: 457068-92-7
Current Sponsor code: MRZ 2/579 mes
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ;Primary end point(s): Total (cumulative) opioid consumption during the first 24 postoperative hours | — |
Countries
Czech Republic
Outcome results
None listed