Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

NCT ID: NCT02711579

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-04-28

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

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.

Conditions

Electrophysiologic Property of Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Celecoxib for electroencephalography

Electroencephalography will be performed before and after celecoxib administration

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Placebo for electroencephalography

Electroencephalography will be performed before and after placebo administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Celecoxib for motor evoked potential

Motor evoked potential will be measured before and after celecoxib administration

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Placebo for motor evoked potential

Motor evoked potential will be measured before and after placebo administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Celecoxib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Il Park, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

H-1509-130-708

Identifier Type: -

Identifier Source: org_study_id