Safety and efficacy of neramexane mesylate as add-on therapy to opioids in cancer patients for the management of chronic pain attributable to skeletal metastases: A randomised, double-blind, placebo-controlled multicentre study

Merz Pharmaceuticals GmbH0 个研究点目标入组 150 人开始时间: 2005年10月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Signed Informed Consent
•Male or female patients between 18 and 75 years of age at a 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.
•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 its 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

•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, hypersensivity or intolerance to neramexane, amantadine, ketamine or memantine.
•Women who are pregnant or breast feading and women of childbearing potential who are not practising medically accepted methods of contraception.

发起方