- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180880
Symptom Based Treatment of Neuropathic Pain
Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial
1. Neuropathic pain in spinal cord injured patients
Inclusion criteria
- pain intensity, visual analogue scale > 3
- a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
- aged ≥20
Method
- Stop pain medications
- Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)
- Check pain intensity (VAS score) with Baron's classification
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the present study, pharmacologic treatment included pregabalin and oxcarbazepine.
Stop medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days.
Pain intensity (VAS score)
4 spontaneous characters
- electric
- burning
- pricking
- numbness
evoked pain
- allodynia
- heat hyperalgesia
- pressure hyperalgesia
Location of neuropathic pain
- neuropathic pain at level of spinal cord injury
- neuropathic pain below level of spinal cord injury
2. Side effects
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kyounggi-do
-
Seongnam-si, Kyounggi-do, Korea, Republic of, 463-712
- CHA University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged than 20 years
- Neuropathic pain symptoms : LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
- Visual analogue scale score of 3 and above
Exclusion Criteria:
- No pregnancy
- systemic disease
- psychiatric disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregabalin and Oxcarbazpepine
Pregabalin and Oxcarbazepine
|
Subjects will take pregabalin for the duration of 2 weeks. The dosage will be increased from 75 mg twice to 150 mg twice a day. Subjects will stop pregabalin for 1 week and take oxcarbazepine 150mg twice.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom based treatment of neuropathic pain
Time Frame: 2 week later
|
Pain intensity using Visual analogue scale (0~100)
|
2 week later
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ju Seok Ryu, MD, CHA University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Neuralgia
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 Enzyme Inducers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Cytochrome P-450 CYP3A Inducers
- Pregabalin
- Oxcarbazepine
Other Study ID Numbers
- NeuropathicPain
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.
Clinical Trials on Neuralgia
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPost Herpetic NeuralgiaUnited States, Colombia, South Africa, Hong Kong, Ukraine, Bulgaria, Croatia, India, Sweden, Czechia, Denmark, Germany, Poland, Russian Federation, Serbia, Slovakia, Taiwan
-
Bial - Portela C S.A.Terminated
-
Odense University HospitalCompletedPost Herpetic NeuralgiaDenmark
-
DepomedCompletedPost Herpetic NeuralgiaUnited States
-
PfizerCompletedPostherpetic NeuralgiaUnited States
-
Yonsei UniversityWithdrawnThe Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic NeuralgiaThoracic Postherpetic NeuralgiaKorea, Republic of
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPostherpetic Neuralgia ( PHN )China
-
Bial - Portela C S.A.Completed
-
Grünenthal GmbHCompletedPost Herpetic Neuralgia
-
Novartis PharmaceuticalsTerminatedPost-herpetic NeuralgiaAustralia, Taiwan, Germany, France, Portugal, Czechia, United Kingdom, Hungary, Spain, Slovakia, Japan, Canada, Denmark, Norway, Austria, Belgium, Poland, Italy, Korea, Republic of
Clinical Trials on Pregabalin and Oxcarbazepine
-
Collaborative Care Initiative, LLCDauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen...UnknownBipolar Depression | Treatment Effectiveness | Measure-based GuidanceUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Prostate Cancer FoundationCompleted
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Desitin Arzneimittel GmbHFGK Clinical Research GmbHTerminated
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompleted
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownPostherpetic NeuralgiaChina
-
Supernus Pharmaceuticals, Inc.CompletedSafety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial EpilepsyPartial EpilepsyUnited States, Poland, Bulgaria, Romania, Canada, Russian Federation, Mexico, Croatia
-
Janssen-Cilag Ltd.Completed