NeuralgiaPhase 4NCT02180880
Symptom Based Treatment of Neuropathic Pain
A Phase 4 study testing Pregabalin and Oxcarbazepine in people with Neuralgia and Spinal Cord Injury, run by Ju Seok Ryu at 1 site in South Korea.
Trial summary
1. Neuropathic pain in spinal cord injured patients 1. Inclusion criteria pain intensity, visual analogue scale > 3 a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above aged ≥20 2. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuralgia, Spinal Cord Injury
- What is being tested?
- Pregabalin and Oxcarbazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No pregnancy
- systemic disease
- psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial
- 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
Read the 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
- Side effects
- Conditions
- Neuralgia, Spinal Cord Injury
- Being tested
- Pregabalin and Oxcarbazepine
- Keywords
- Neuralgia, Spinal cord, Oxcarbazepine, Pregabalin, Drug therapy, Algorithms
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin and OxcarbazepineDrug
Also called Lyrica and Oxcarb
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin and Oxcarbazpepine | Experimental | Pregabalin and Oxcarbazepine Receives: Drug: Pregabalin and Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom based treatment of neuropathic pain
Pain intensity using Visual analogue scale (0~100)
Measured: 2 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ju Seok Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ju Seok Ryu, CHA University
- Investigators
- Ju Seok Ryu, MD, Study chair, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180880
- Sponsor's protocol ID
- NeuropathicPain
- Status last verified
- Aug 2014
- First submitted
- 5 Jun 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Min K, Oh Y, Lee SH, Ryu JS. Symptom-Based Treatment of Neuropathic Pain in Spinal Cord-Injured Patients: A Randomized Crossover Clinical Trial. Am J Phys Med Rehabil. 2016 May;95(5):330-8. doi: 10.1097/PHM.0000000000000382.
PubMed 26368836
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02180880
- Acronym / sponsor ID
- NeuropathicPain
- Conditions
- Neuralgia, Spinal Cord Injury
- Keywords
- Neuralgia, Spinal cord, Oxcarbazepine, Pregabalin, Drug therapy, Algorithms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ju Seok RyuUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
- Side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregabalin and Oxcarbazpepine | Experimental | Drug: Pregabalin and OxcarbazepinePregabalin and Oxcarbazepine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- No pregnancy
- systemic disease
- psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin and OxcarbazepineAlso: Lyrica and OxcarbSubjects 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. | Drug | Pregabalin and Oxcarbazpepine |
Primary outcome
Symptom based treatment of neuropathic pain
Time frame: 2 week later
Pain intensity using Visual analogue scale (0~100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 26368836Min K, Oh Y, Lee SH, Ryu JS. Symptom-Based Treatment of Neuropathic Pain in Spinal Cord-Injured Patients: A Randomized Crossover Clinical Trial. Am J Phys Med Rehabil. 2016 May;95(5):330-8. doi: 10.1097/PHM.0000000000000382.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Seok Ryu, MD study chair
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Oxcarbazepine in people with Neuralgia and Spinal Cord Injury, run by Ju Seok Ryu at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom based treatment of neuropathic pain (time frame: 2 week later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.