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

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

Purpose

Primary:

Change of volume of perihematomal edema as assessed by brain CT.

Secondary:

The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

Condition	Intervention
Intracerebral Hemorrhage	Drug: celecoxib medication

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Edema

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Change of volume of perihematomal edema as assessed by brain CT [ Time Frame: at 1st day of admission and repeated at 7th±1 day ] [ Designated as safety issue: No ]
Brain CT scanning for measurement of volumes of ICH and perihematomal edema was performed at 1st day of admission and repeated at 7th±1 day. Considering some possible errors in measurement of edema volume, at follow-up CT scan, the decrease more than 20% from the initial edema volume was coded as "decreased" edema volume; the increase more than 20% was coded as "increased"; the change between -20% and 20% was coded as "unchanged".

Secondary Outcome Measures:

The neurological status at 90 day using E-GOS and mRS [ Time Frame: 90 days after onset. ] [ Designated as safety issue: No ]
The secondary endpoints were neurological status at 90 day using E-GOS and mRS. Good outcome was defined as 6 or more in E-GOS score, and 2 or less in mRS score.
Change of ICH volume between the initial and the follow-up CT scans [ Time Frame: Day1, Day 7 ] [ Designated as safety issue: No ]
Change of ICH volume between the initial and the follow-up CT scans. In this analysis, the 20% criterion was applied as mentioned in the edema analysis
Major and minor adverse events [ Time Frame: anytime for 3 months ] [ Designated as safety issue: Yes ]
the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

Estimated Enrollment:	40
Study Start Date:	October 2007
Study Completion Date:	August 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 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. Other Name: celecoxib(celebrex)

Detailed Description:

INCLUSION/EXCLUSION CRITERIA
1. 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
  - Informed consent before study
2. Exclusion Criteria
  - Planned surgical evacuation of hematoma within 24hrs
  - Secondary ICH such as trauma or aneurysmal rupture
  - Taking anticoagulation previously
  - Pregnancy,known allergy to celecoxib, severe liver or kidney disease, or poor performance state were excluded
  - Other physical condition, making the patient difficult to participate in this study (decided by the neurologist or the physician).
OTHER THERAPY

-No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms
STUDY DESIGN Multicenter, prospective randomized, comparative open with blinded endpoints (PROBE) trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage

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

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

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.

Responsible Party:	Jae-Kyu Roh/MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00526214 History of Changes
Other Study ID Numbers:	H-0704-028-205, 12-2007-0084
Study First Received:	September 6, 2007
Last Updated:	March 26, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Spontaneous intracerebral hemorrhage
Acute Spontaneous, Supratentorial intracerebral hemorrhage

Additional relevant MeSH terms:

Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012