Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02711579

Collaborator

(none)

Enrollment

Location

Arms

11.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer

Condition or Disease	Intervention/Treatment	Phase
Electrophysiologic Property of Brain	Drug: Celecoxib Drug: Placebo	Phase 1

Detailed Description

Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.

In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Impact of Selective Cyclooxygenase-2 Inhibitor, Celecoxib on Cortical Excitability and Electrophysiological Property in Brain of Healthy Volunteer: Randomized, Double-blind, Placebo-controlled Study

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Apr 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib for electroencephalography Electroencephalography will be performed before and after celecoxib administration	Drug: Celecoxib
Placebo Comparator: Placebo for electroencephalography Electroencephalography will be performed before and after placebo administration	Drug: Placebo
Experimental: Celecoxib for motor evoked potential Motor evoked potential will be measured before and after celecoxib administration	Drug: Celecoxib
Placebo Comparator: Placebo for motor evoked potential Motor evoked potential will be measured before and after placebo administration	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer [4 hours after medical treatment]
Power spectrum will be measured by electroencephalography
Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer [7 days after medical treatment]
Cortical excitability will be measured by transmagnetic stimulation

Secondary Outcome Measures

Power spectral change by celecoxib in different locations and different frequency band. [4 hours and 7 days after medical treatment]
Power spectrum will be measured by electroencephalography

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male or female aged between 20 and 50 years.
Signed voluntary written informed consent.
Body mass index between 16.0 and 30.0 kg/m2.

Exclusion Criteria:

History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
History of any kind of medication(s) within 1 week before screening.
Presence of clinically significant electrocardiogram abnormality at screening.
aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
Serum creatinine levels : greater than 1.5 × upper normal limit.
Platelet counts lower than 100,000 / μL
Serum potassium : greater than 5.5 mmol/L
Female who is pregnant, breastfeeding, or intends to become pregnant.
History of noncompliance with medications.
History of alcohol abuse.
Participation in drug study within 30 days before screening.
Galactose intolerance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Kyung-Il Park, MD., PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02711579

Other Study ID Numbers:

H-1509-130-708

First Posted:

Mar 17, 2016

Last Update Posted:

May 22, 2017

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Celecoxib

Study Results

No Results Posted as of May 22, 2017