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

• Conditions: Moderate to severe chronic pain (cancer pain); MedDRA version: 7.1Level: LLTClassification code 10058019

• Registration Number: EUCTR2004-002520-18-CZ
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.