Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

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

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

Study Overview

• Status: Completed
• Conditions: Electrophysiologic Property of Brain
• Intervention / Treatment: Drug: Placebo; Drug: Celecoxib

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power spectral change by celecoxib in different locations and different frequency band.	Power spectrum will be measured by electroencephalography	4 hours and 7 days after medical treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: H-1509-130-708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No