Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study - Full Text View

Purpose

Primary:

To evaluate the safety of celebrex medication for the patients with ICH.

Secondary:

To detect the effectiveness of celebrex for human intracerebral hemorrhages and to give the preliminary data, support the design of the sample size calculation and the clinical assessment for the future Phase II clinical trials.

Condition	Intervention
Intracerebral Hemorrhage	Drug: celecoxib medication

MedlinePlus related topics:

Edema

ChemIDplus related topics:

Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Multi-Center, Prospective Randomized, Comparative Open With Blinded Endpoints (PROBE) Trial to Assess the Safety and Effectiveness of Administration of Celecoxib in Patients With Intracerebral Hemorrhage

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Brain edema, Significant adverse events, mRS, Bathel index [ Time Frame: one year ]

Secondary Outcome Measures:

-Clinical assessment; NIHSS /Glasgow Coma Scale -Self-assessment; Barthel index/m-Rankin Scale/Extended Glasgow outcome scale -Brain CT (edema size, hematoma size)

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: No Intervention In the control group, patients will not take the drug. We do not use placebo drugs.	Drug: celecoxib medication In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
Supratentorial location of hemorrhage
Older than 17 yrs

Exclusion Criteria:

Planned surgical evacuation of hematoma within 24hrs
Secondary ICH due to trauma or aneurismal rupture or etc
Taking antithrombotics or other NSAIDs previously
Pregnancy
Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526214

Contacts


Contact: Hee-Kwon Park, MD	82-2-2072-1988	parkhkwon@hanmail.net

Contact: Seung-Hoon Lee, Md, PhD

Locations


Korea, Republic of
	Seoul National University Hospital	Not yet recruiting
	Seoul, Korea, Republic of, 110-744
	Contact: Hee-kwon Park, MD, 82-2-2072-1988 parkhkwon@hanmail.net
	Principal Investigator: Jae-Kyu Roh, MD, PhD
	Sub-Investigator: Seung-Hoon Lee, MD, PhD

Sponsors and Collaborators

Seoul National University Hospital

Investigators


Principal Investigator:	Jae-Kyu Roh, MD, PhD	Seoul National University Hospital

More Information

Publications:

Chu K, Jeong SW, Jung KH, Han SY, Lee ST, Kim M, Roh JK. Celecoxib induces functional recovery after intracerebral hemorrhage with reduction of brain edema and perihematomal cell death. J Cereb Blood Flow Metab. 2004 Aug;24(8):926-33.

Study ID Numbers:	H-0704-028-205, 12-2007-0084
First Received:	September 6, 2007
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00526214
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Spontaneous intracerebral hemorrhage

Acute Spontaneous, Supratentorial intracerebral hemorrhage

Study placed in the following topic categories:

Cerebral Hemorrhage

Celecoxib

Vascular Diseases

Central Nervous System Diseases

Intracranial Hemorrhages

Brain Diseases

Hemorrhage

Cerebrovascular Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Pathologic Processes

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00526214