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

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

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	Phase
Intracerebral Hemorrhage	Drug: celecoxib medication	Phase I Phase II

Drug Information available for: Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo 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:

Significant adverse events [ Time Frame: anytime for 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

NIHSS [ Time Frame: Day1,3,7,14 ] [ Designated as safety issue: Yes ]
mRS [ Time Frame: Day1, Day 90 ] [ Designated as safety issue: Yes ]

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

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.

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 aneurismal rupture
  - Taking anticoagulation previously
  - Pregnancy
  - 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

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	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.

Responsible Party:	Seoul National University Hospital ( Jae-Kyu Roh/MD, PhD )
Study ID Numbers:	H-0704-028-205, 12-2007-0084
Study First Received:	September 6, 2007
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00526214 History of Changes
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:

Anti-Inflammatory Agents
Cerebral Hemorrhage
Celecoxib
Cyclooxygenase Inhibitors
Vascular Diseases
Central Nervous System Diseases
Intracranial Hemorrhages
Hemorrhage

Brain Diseases
Cerebrovascular Disorders
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Cerebral Hemorrhage
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Celecoxib
Cyclooxygenase Inhibitors
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009