Saftey and efficacy of two different doses of Neramexane mesylate as preemptive analgesic and add-on therapy to opioids in the management of postoperative pain. A randomised, double-blind, placebo-controlled, sequential, dose-escalating, multicentre study. - pre-emptive Analgesie

Conditions: Moderate to severe acute postoperative pain
MedDRA version: 7.1Level: LLTClassification code 10054711

Registration Number: EUCTR2004-001782-18-CZ

Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures