Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome (RUFPTPS)

University of Zurich (UZH)

Status and phase

Withdrawn

Phase 2

Conditions

Peripheral Nerve Injuries

Pain

Treatments

Drug: Rufinamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02095899

2013-253

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria, Run-In Phase:

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

Inclusion criteria, Treatment Phase:

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