Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome (RUFPTPS)

July 20, 2015 updated by: University of Zurich

Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Institut of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rufinamide
- oral Rufinamide administration as ad-on to Oxycodone
Drug: Rufinamide
2x200mg up to max 2x800mg a day Titration over 20days
Other Names:
  • Inovelon
Placebo Comparator: Manitol
- oral Placebo administration - as ad-on to Oxycodone
Drug: Rufinamide
2x200mg up to max 2x800mg a day Titration over 20days
Other Names:
  • Inovelon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area of punctuate hyperalgesia immediately after topical capsaicin.
Time Frame: 2h after capsaicin removal
The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo.
2h after capsaicin removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Konrad Maurer, MD, University Hospital Zurich, Institut of Anaesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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