Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial is a phase IIa human clinical study, in which 60 patients with intracerebral hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. Patients will be randomly assigned as treatment group or control group as 1:1 distribution. Early initiation of celecoxib within 6 h after ICH and treatment for 21 days will be performed. The safety will be evaluated by drug adverse effects. The efficacy will be assessed by hematoma expansion, brain edema, and 3-month modified Rankin scale.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• Acute ICH patients able to take the first dose within 6 hours after onset

• ICH location at basal ganglion or thalamus

• ICH volume \< 30 mL

• Normal renal function (creatinine \[Cr\] ≤ 1.3 mg/dL)

• No surgical indication

• Signed informed consent

• Consciousness clear or mild drowsiness

• Age 20-80 years old

Locations
Other Locations
Taiwan
Natinal Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Shin-Joe Yeh, MD PhD
shinjoeyeh@gmail.com
886-2-23123456
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Celebrex treatment arm
Celecoxib 200 mg/dose, started within 6 h after onset, then one dose per day for 21 days.
No_intervention: Control arm
No trial medication will be given.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov