A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer

Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00164931

Enrollment

240

Registered

2005-09-14

Start date

2003-10-31

Completion date

Unknown

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy

Brief summary

A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

Detailed description

We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis. When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement. Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding. We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.

Interventions

DRUGIntravenous omeprazole infusion

PROCEDUREScheduled second endoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb * age 15 - 90 years * Written consent available

Exclusion criteria

* ulcer bleeding not controlled in first endoscopy * Bleeding from malignant ulcer or tumor * Bleeding from Dieulafoy lesion/ angiodysplasia * Bleeding from injection sclerotherapy ulcer * Patient with ASA category 5

Design outcomes

Primary

Measure	Time frame
2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl	—
4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs	—
Recurrent bleeding within 30 days after initial endoscopy defined as -	—
Clinical criteria (anyone of the below)	—
1. Haemetmesis or fresh blood from Ryles tube	—
AND Endoscopic criteria of Forrest I a, b or II a, b	—
3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy	—

Secondary

Measure	Time frame
2. Mortality	—
3. Length of Hospital stay	—
4. Transfusion	—
1. The rate of surgery	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026