NCT02180880

Brief Summary

1\. Neuropathic pain in spinal cord injured patients

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

June 5, 2014

Last Update Submit

August 18, 2014

Conditions

NeuralgiaSpinal Cord Injury

Keywords

NeuralgiaSpinal cordOxcarbazepinePregabalinDrug therapyAlgorithms

Outcome Measures

Primary Outcomes (1)

  • Symptom based treatment of neuropathic pain

    Pain intensity using Visual analogue scale (0\~100)

    2 week later

Study Arms (1)

Pregabalin and Oxcarbazpepine

EXPERIMENTAL

Pregabalin and Oxcarbazepine

Drug: Pregabalin and Oxcarbazepine

Interventions

Pregabalin and OxcarbazepineDRUG

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.

Also known as: Lyrica and Oxcarb
Pregabalin and Oxcarbazpepine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No pregnancy
  • systemic disease
  • psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA University

Seongnam-si, Kyounggi-do, 463-712, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26368836DERIVED

MeSH Terms

Conditions

NeuralgiaSpinal Cord Injuries

Interventions

PregabalinOxcarbazepine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ju Seok Ryu, MD

    CHA University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 5, 2014

First Posted

July 3, 2014

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

KR(1)