Oral Omeprazole in Bleeding Peptic Ulcer

November 22, 2019 updated by: Zeinab Nasr El Din Ahmed, Assiut University

Oral Versus Intravenous Omeprazole in Management of Bleeding Peptic Ulcer: Randomized Controlled Trial

Find out if there is a significant difference between clinical outcome among the patients with bleeding peptic ulcer treated with oral omeprazole compared to those treated with intravenous omeprazole.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Globally, Peptic ulcer disease is the most common cause of upper gastrointestinal bleeding (UGIB), accounting for about 50% of cases. It remains a serious medical problem with significant morbidity and mortality (1, 2). However, in Egypt, bleeding peptic ulcer comes second to the bleeding varices in order of frequency (approximately 30%) (3).

Over the past 20 years, mortality resulting from bleeding peptic ulcer significantly decreased through researches on primary endoscopic hemostasis, due to improvement in pre- and post-endoscopic management, as well as identification of patients at a risk of catastrophic events-for close observation and focused intensive management (4).However, the risk of patients with bleeding peptic ulcers significantly increased owing to the aging population with multiple comorbidities, as well as the increasing use of aspirin and non-steroidal anti-inflammatory drugs (5).

Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcer and is now recommended as the first hemostatic modality for these patients. However, there is a high risk of peptic ulcer re-bleeding in 14-36% of patients, in spite of efficient endoscopic intervention (6).

Intravenous proton pump inhibitors (PPIs) are effective as adjuvant pharmacotherapy in preventing re-bleeding in these patients (7).

Gastric acid inhibits clot formation and promotes clot lyses and accordingly, disturbs hemostasis of ulcers in the stomach and duodenum (8). Therefore, reduction of gastric acid secretion can prevent ulcer re-bleeding.

The use of high-dose intravenous PPIs is standard practice in the management of upper gastrointestinal bleeding (9).

High dose IV PPI has faster adequate acid suppression effect (gastric acid PH > 6) than high dose oral PPI . In addition, Compared to standard dose of oral PPI, high dose oral PPI has faster acid suppression (10, 11). However, the optimal route, dose, and duration of PPI therapy after endoscopic therapy of a bleeding peptic ulcer remain controversial.

UGIB continues to represent a significant clinical and economic burden to society. Intravenous PPI therapy is more expensive than oral one. Therefore, the therapy has to be assessed from a cost-effectiveness perspective (12).

Several controlled trials and meta-analyses have shown the comparable efficacy of IV and oral PPI in treating ulcers at high risk of re-bleeding after endoscopic therapy. However, further studies to confirm their results were recommended (13, 14).

The investigators will evaluate and compare the efficacy and safety profile of oral PPI compared to IV PPI in preventing re-bleeding from peptic ulcers.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zeinab Nasr El Din Ahmed, resident doctor
  • Phone Number: +201021659698
  • Email: zeinabnasr9@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Peptic ulcer of the esophagus (lower part), stomach, and duodenum with one or more endoscopic signs of high risk for re-bleeding (ulcer bed exhibiting active bleeding (spurting/oozing), non-bleeding visible vessel, and adherent clot).

Exclusion Criteria:

  • Pregnant patients.
  • Pediatric patients (less than 18 years).
  • Ulcer with endoscopic signs suspicious of neoplastic disease (greater than 3 cm, irregular shape, uneven base, irregular edges, moth eaten appearance of peri ulcer folds, associated with a mass)
  • Use of PPI 14 days or less before enrollment.
  • Other sources of UGIB.
  • Bleeding tendency (platelet count <50,000/mL, prothrombin time > 14 sec, prothrombin concentration <30%, anticoagulant therapy)
  • Uremia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oral omeprazole
oral omeprazole in bleeding peptic ulcer after endoscopic therapy 40 mg twice daily for 72 hours
Drug: Omeprazole

Pre endoscopically: all patients will receive 80 mg omeprazole by 30 minute IV infusion.

After performing upper endoscopy (with initial hemostasis), the patient will be randomly allocated into two groups; group A patients will receive oral omeprazole, while group B patients are intended to receive IV omeprazole.

For patients of group A, omeprazole 40 mg will be administrated orally every 12 hours for 72 hours. Regarding group B, continuous infusion of omeprazole will be administrated at a rate of 8 mg/hour, for 72 hours.
Active Comparator: intravenous omeprazole
intravenous omeprazole in bleeding peptic ulcer after endoscopic therapy as continuous infusion at rate of 8 mg/hour for 72 hours
Drug: Omeprazole

Pre endoscopically: all patients will receive 80 mg omeprazole by 30 minute IV infusion.

After performing upper endoscopy (with initial hemostasis), the patient will be randomly allocated into two groups; group A patients will receive oral omeprazole, while group B patients are intended to receive IV omeprazole.

For patients of group A, omeprazole 40 mg will be administrated orally every 12 hours for 72 hours. Regarding group B, continuous infusion of omeprazole will be administrated at a rate of 8 mg/hour, for 72 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent bleeding
Time Frame: 15 days
Re-bleeding will be suspected if hematemesis or melena recur or of the patient develop one or more of the following: orthostatic hypotension, unstable vital signs (systolic blood pressure< 90 mmHg and pulse rate> 120/min), reduction of hemoglobin level> 2 gm/dL (despite blood transfusion), during 24 hour period.
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
-Length of hospital stay. -Admission to ICU. - Blood transfusion (number of units of packes RBCs) -Angioembolization. -Surgery for uncontrolled recurrent bleeding.
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bleeding peptic ulcer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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