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

Condition(s) targeted: Intracerebral Hemorrhage

Intervention: celecoxib medication (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Kyu Roh, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Hee-Kwon Park, MD, Phone: 82-2-2072-1988, Email: parkhkwon@hanmail.net

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.

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

Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Significant adverse events

Secondary outcome:

NIHSS

mRS

Detailed description: 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 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).

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

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

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Hee-kwon Park, MD,, Phone: 82-2-2072-1988, Email: parkhkwon@hanmail.net
Jae-Kyu Roh, MD, PhD, Principal Investigator
Seung-Hoon Lee, MD, PhD, Sub-Investigator

Related 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.

Starting date: September 2007
Ending date: December 2009
Last updated: October 18, 2008