Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study

NCT ID: NCT00526214

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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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

Detailed Description

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1. 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).
2. OTHER THERAPY

-No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms
3. 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

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

In the control group, patients will not take the drug. We do not use placebo drugs.

Group Type NO_INTERVENTION

No interventions assigned to this group

2

In the intervention group, patients will take celecoxib.

Group Type EXPERIMENTAL

celecoxib medication

Intervention Type DRUG

In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.

Interventions

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celecoxib medication

In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.

Intervention Type DRUG

Other Intervention Names

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celecoxib(celebrex)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-Kyu Roh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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. doi: 10.1097/01.WCB.0000130866.25040.7D.

Reference Type BACKGROUND
PMID: 15362723 (View on PubMed)

Other Identifiers

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12-2007-0084

Identifier Type: -

Identifier Source: secondary_id

H-0704-028-205

Identifier Type: -

Identifier Source: org_study_id

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