Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome

NCT ID: NCT02095899

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-05-31

Brief Summary

The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

Detailed Description

Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.

Conditions

Peripheral Nerve Injuries; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rufinamide

\- oral Rufinamide administration as ad-on to Oxycodone

Group Type: EXPERIMENTAL

Rufinamide

Intervention Type: DRUG

2x200mg up to max 2x800mg a day Titration over 20days

Manitol

\- oral Placebo administration - as ad-on to Oxycodone

Group Type: PLACEBO_COMPARATOR

Rufinamide

Intervention Type: DRUG

2x200mg up to max 2x800mg a day Titration over 20days

Interventions

Rufinamide

2x200mg up to max 2x800mg a day Titration over 20days

Intervention Type: DRUG

Other Intervention Names

Inovelon

Eligibility Criteria

Inclusion Criteria

• Age: 18-75 years
• Weight: 50 - 100kg
• Height: 155 - 195cm
• Sufficient command of German language
• Patient after thoracotomy
• Pain duration of more than 6 month.
• Diagnosis of Neuropathic Pain (DN4 questionnaire)
• Average baseline mean last week pain intensity =5 on NRS (numerical rating scale)
• Signed and dated informed consent

• Stable analgesic regimen for at least 7 days prior to randomisation
• Patients not reaching a NRS = 3 (numeric rating scale) with the baseline individually dose adjusted treatment (oxycodone).

Exclusion Criteria

• Contraindications to the class of drugs under study, e.g. (rufinamide, oxycodone) known hypersensitivity or allergy this class of drugs
• Hypersensitivity to triazole derivates - antifungal drugs including: fluconazole (e.g. Diflucan®), posaconazole (Noxafil®), itraconazole (Sporanox®), voriconazole (Vfend®)
• Lactose intolerance, galactosemia or galactokinase deficiency, glucose-galactose malabsorption
• Use of topical analgesics, or nerve block of the affected or adjacent dermatomes (less than to 2 weeks prior to the therapy onset visit or during the study period)
• Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular disease, etc)
• Creatinine clearance = 30 ml/min (estimated from serum creatinine using the Cockcroft - Gault formula) were excluded
• Known drug (opiate or other) or alcohol abuse
• Contraindication to the use of oxycodone
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Participation in another study with investigational drugs within the 30 days preceding and during the present study
• Enrollment of the investigators, his/her family members, employees and other dependent persons
• Known neurological disease with peripheral manifestations including neuropathy associated with disease such as diabetes
• Known sensory changes from other medical conditions (e.g. infections affecting the investigation areas, post-herpetic neuralgia)
• Epilepsy
• Abnormal electrocardiogram (especially Familial Short QT syndrome)
• Patient having another pain condition with greater pain intensity
• Repeated thoracic surgeries
• Pneumonectomy or chest wall resection
• Bilateral thoracic surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad Maurer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Institut of Anaesthesiology

Locations

University Hospital Zurich, Institut of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

2013-253

Identifier Type: -

Identifier Source: org_study_id