NCT00633035

Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

Completed Phase 4 Last updated 12 October 2013

What this trial tests

Phase 4 trial testing esomeprazole 40 mg in Ulcer in 60 participants. Completed in 1 April 2010.

Timeline

1 September 2007

Primary endpoint
1 March 2010

1 April 2010

Quick facts

Lead sponsor	Far Eastern Memorial Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	1 September 2007
Primary completion	1 March 2010
Estimated completion	1 April 2010
Sites	1 location across Taiwan

Drugs / interventions tested

• esomeprazole 40 mg — full drug profile →
• famotidine 20 mg — full drug profile →

Conditions studied

• Ulcer — all drugs for Ulcer →

Sponsor

Far Eastern Memorial Hospital

Who can join

Adults 18 to 90, any sex, with Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• UGI bleeding: hematemesis or much coffee ground substance (> 60 ml) from NG, tarry stool, decrease of Hb more than 2g/dl and endoscopic proof of bleeder
  Time frame: 7 days within the period of prophylactic medication use

Sponsor's own description

Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the tablets are soluble for the use of tube feeding. Our previous study showed that there was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence of nosocomial pneumonia was also similar.

We will enroll those patients that have received intracranial surgery and admitted to neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The impact of proton pump inhibitor exposure on pneumonia: an updated meta-analysis based on randomized controlled trials.
   Wu Z, Wu Y, Xiang Z, Qiu Y, et al · · 2025 · cited 1× · PMID 41230098 · DOI 10.3389/fphar.2025.1713256