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Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome

WithdrawnPhase 2NCT02095899
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.
Conditions
  • Peripheral Nerve Injuries
  • Pain
Interventions
  • Drug: Rufinamide
Sponsor
University of Zurich
Start date
2014-03
Primary completion
2015-05
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
Switzerland
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 prese…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02095899