NCT02711579

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2016

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

First Submitted

Initial submission to the registry

March 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
Last Updated

May 22, 2017

Status Verified

December 1, 2016

Enrollment Period

12 months

First QC Date

March 8, 2016

Last Update Submit

May 18, 2017

Conditions

Electrophysiologic Property of Brain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Power spectral change by celecoxib in different locations and different frequency band.

    4 hours and 7 days after medical treatment

Study Arms (4)

Celecoxib for electroencephalography

EXPERIMENTAL

Electroencephalography will be performed before and after celecoxib administration

Drug: Celecoxib

Placebo for electroencephalography

PLACEBO COMPARATOR

Electroencephalography will be performed before and after placebo administration

Drug: Placebo

Celecoxib for motor evoked potential

EXPERIMENTAL

Motor evoked potential will be measured before and after celecoxib administration

Drug: Celecoxib

Placebo for motor evoked potential

PLACEBO COMPARATOR

Motor evoked potential will be measured before and after placebo administration

Drug: Placebo

Interventions

CelecoxibDRUG
Celecoxib for electroencephalographyCelecoxib for motor evoked potential
PlaceboDRUG
Placebo for electroencephalographyPlacebo for motor evoked potential

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kyung-Il Park, MD., PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 17, 2016

Study Start

May 1, 2016

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

May 22, 2017

Record last verified: 2016-12

Locations

KR(1)