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Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

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ClinicalTrials.gov Identifier: NCT02711579
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.


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Study Type : Interventional  (Clinical Trial)
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 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

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



Primary Outcome Measures :
  1. Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer [ Time Frame: 4 hours after medical treatment ]
    Power spectrum will be measured by electroencephalography

  2. Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer [ Time Frame: 7 days after medical treatment ]
    Cortical excitability will be measured by transmagnetic stimulation


Secondary Outcome Measures :
  1. Power spectral change by celecoxib in different locations and different frequency band. [ Time Frame: 4 hours and 7 days after medical treatment ]
    Power spectrum will be measured by electroencephalography



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711579


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Kyung-Il Park, MD., PhD Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02711579     History of Changes
Other Study ID Numbers: H-1509-130-708
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action