Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

NCT ID: NCT01302275

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.

Detailed Description

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Conditions

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Polyneuropathy Peripheral Nerve Injury Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oxcarbazepine

Oxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks.

Group Type EXPERIMENTAL

Oxcarbazepine

Intervention Type DRUG

Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day

placebo

Group Type PLACEBO_COMPARATOR

Oxcarbazepine

Intervention Type DRUG

Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day

Interventions

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Oxcarbazepine

Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day

Intervention Type DRUG

Other Intervention Names

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Trileptal

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years old
* definite or probable neuropathic pain
* diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
* pain duration \> 3 months
* pain rating at baseline \>= 4 point NRS
* Informed consent

Exclusion Criteria

* other non-neuropathic pain condition
* allergy to oxcarbazepine
* renal or hepatic impairment
* epilepsy
* depression and other serious psychiatric disorders
* serious medical condition
* previous treatment for neuropathic that cannot be stopped
* pregnancy
* patients expected not to be able to comply with study protocol
* treatment with anticonvulsants, antidepressant or opioids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Pain Research Center

OTHER

Sponsor Role collaborator

Innovative Medicines Initiative

OTHER

Sponsor Role collaborator

Søren H. Sindrup

OTHER

Sponsor Role lead

Responsible Party

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Søren H. Sindrup

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Søren H Sindrup, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Odense University Hospital

Locations

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Danish Pain Research Center, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Department of Neurology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IMIOXC

Identifier Type: -

Identifier Source: org_study_id

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