Trial record 5 of 7 for:
Open Studies | "Peripheral Nerve Injuries"
Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain (IMIOXC)
This study is currently recruiting participants.
Verified February 2011 by Odense University Hospital
Sponsor:
Odense University Hospital
Collaborators:
Danish Pain Research Center
Europain consortium, Innovative Medicines Initiative (IMI), European Union
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01302275
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polyneuropathy Peripheral Nerve Injury Postherpetic Neuralgia |
Drug: Oxcarbazepine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Odense University Hospital:
Primary Outcome Measures:
- Total pain rated on numeric rating scale [ Time Frame: Measurements from week 6 of treatment period ] [ Designated as safety issue: No ]Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.
Secondary Outcome Measures:
- Response defined as at least 50% reduction in pain score [ Time Frame: Week 6 of each treatment period vs. baseline ] [ Designated as safety issue: No ]Response defined as 50% reduction in pain score (median value week 6 of treatment period compared to median value during baseline period). Repsonse rates for each treatment and each phenotype will be calculated
- Neuropathic Pain Symptom Inventory [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]Different pain dimensions as rated by Neuropathic Pain Symptom Inventory
- Patient Global Impression of Change [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]
- Rating of evoked pain [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]Rating on numeric rating scales of pain induced by stimulation with cold rollers, stiff von Frey hain and dynamic touch with rubber sponge
- Sleep disturbance [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]Numeric rating scale ratings of pain induced sleep disturbance, median value of ratings from week 6 of each treatment period
- Quality of life [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]Rating of quality of life with numeric rating scale
- Use of escape medication [ Time Frame: Week 6 of each treatment period ] [ Designated as safety issue: No ]Number of paracetamol 500 mg used during the last week of each treamtent period
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: 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
Other Name: Trileptal
|
| Placebo Comparator: placebo |
Drug: 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
Other Name: Trileptal
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302275
Contacts
| Contact: Søren H Sindrup, MD | +45 65412471 | soeren.sindrup@ouh.regionsyddanmark.dk |
| Contact: Dyveke T Demant, MD | +45 65412485 | dyveke.demant@gmail.com |
Locations
| Denmark | |
| Danish Pain Research Center, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Nanna B Finnerup, MD +45 89493455 finnerup@ki.au.dk | |
| Contact: Troels S Jensen, MD +45 89494137 tsjensen@ki.au.dk | |
| Principal Investigator: Nanna B Finnerup, MD | |
| Sub-Investigator: Karen Lund, MD | |
| Department of Neurology, Odense University Hospital | Recruiting |
| Odense, Denmark, DK-5000 | |
| Contact: Søren H Sindrup, MD +45 65412471 soeren.sindrup@ouh.regionsyddanmark.dk | |
| Contact: Dyveke T Demant, MD +45 65412485 dyveke.demant@gmail.com | |
| Sub-Investigator: Dyveke T Demant, MD | |
| Principal Investigator: Søren H Sindrup, MD | |
Sponsors and Collaborators
Odense University Hospital
Danish Pain Research Center
Europain consortium, Innovative Medicines Initiative (IMI), European Union
Investigators
| Principal Investigator: | Søren H Sindrup, MD | Department of Neurology, Odense University Hospital |
More Information
No publications provided
| Responsible Party: | Søren H. Sindrup, Department of Neurology, Odense University Hospital, Denmark |
| ClinicalTrials.gov Identifier: | NCT01302275 History of Changes |
| Other Study ID Numbers: | IMIOXC |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Odense University Hospital:
|
neuropathic pain oxcarbazepine pain mechanism |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Polyneuropathies Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Oxcarbazepine Carbamazepine Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013