Moderate to severe chronic pain (cancer pain) MedDRA version: 7.1 Level: LLT Classification code 10058019
Conditions
Interventions
Product Name: Neramexane mesylate film-coated tablets 25 mg
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: Signed Informed Consent. Male or female patients between 18 and 75 years of age at baseline with a confirmed diagnosis of cancer. Bone metastases confirmed by X-ray, CT, MRI, or PET (positron emission tomography) Movement-related pain due to skeletal metastases. A daily dose of = 60 mg opioids expressed as oral morphine equivalents, stable dose for at least one week (minimum 5 days) prior to baseline, i.e. no dose adjustment by investigator necessary. Worst pain intensity over the last 24 hours must have been > 4 on the 11-point Numerical Rating Scale during the last three consecutive days prior to baseline. Patient is capable to understand the nature of the study and the procedures to be followed. Patient is expected to comply with the scheduled visits and dosing scheme. Are the trial subjects under 18? 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: Life expectancy < 4 months. Use of opioid analgesics other than morphine, immediate and / or sustained release, hydromorphone, oxycodone, tramadol (doses not exceeding 400 mg / day), or fentanyl (transdermal and transmucosal formulations). Patients with clinically relevant coexisting diseases other than cancer, or any clinically relevant haematological, endocrine, cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal, neurological (including any form of epilepsy), or psychiatric diseases. 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 known allergy, hypersensitivity, or intolerance to neramexane, amantadine, ketamine, or memantine. Women who are pregnant or breast feeding, and women of childbearing potential who are not practising medically accepted methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): In this study two primary efficacy parameters will be analysed simultaneously: changes from baseline in both parameters, opioid consumption and pain intensity, compared to week 8. ;Main Objective: The primary objective of the present study is to generate first data on the safety and efficacy of Neramexane mesylate as co-analgesic to opioids in moderate to severe bone metastases pain. | — |
Countries
Czech Republic, Germany
Outcome results
None listed