Symptom Based Treatment of Neuropathic Pain | NCT02180880

Studies
Symptom Based Treatment of Neuropathic Pain

NCT02180880

Sponsor

Ju Seok Ryu

Status

Completed

Last Update Posted

Aug 20, 2014Estimated

Enrollment

63Actual

Phase

Phase 4

Conditions

Neuralgia
Spinal Cord Injury

Interventions

Pregabalin and Oxcarbazepine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jun 5, 2014

First Submission Date that Met QC Criteria

Jul 1, 2014

First Posted Date

Jul 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2014

Last Update Posted Date

Aug 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ju Seok Ryu, Assistant professor, CHA UniversitySponsor-Investigator

Lead Sponsor

Ju Seok RyuOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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)
1. 4 spontaneous characters
  - electric
  - burning
  - pricking
  - numbness
2. evoked pain
  - allodynia
  - heat hyperalgesia
  - pressure hyperalgesia
Location of neuropathic pain
1. neuropathic pain at level of spinal cord injury
2. neuropathic pain below level of spinal cord injury

2. Side effects

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregabalin and Oxcarbazpepine	Experimental	Pregabalin and Oxcarbazepine	Drug: Pregabalin and Oxcarbazepine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin and Oxcarbazepine	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom based treatment of neuropathic pain	Pain intensity using Visual analogue scale (0~100)	2 week later

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ju Seok Ryu, MD	CHA University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHA University		Seongnam-si	Kyounggi-do	463-712	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26368836	Derived	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.

ID	Term
D009437	Neuralgia
D013119	Spinal Cord Injuries

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic