Oral Omeprazole in Bleeding Peptic Ulcer

NCT04170270 | Unknown Early Phase 1

• 1 other identifier: bleeding peptic ulcer
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bleeding Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• recurrent bleeding

  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 Outcomes (1)

• -Length of hospital stay. -Admission to ICU. - Blood transfusion (number of units of packes RBCs) -Angioembolization. -Surgery for uncontrolled recurrent bleeding.

  15 days

Study Arms (2)

oral omeprazole

EXPERIMENTAL

oral omeprazole in bleeding peptic ulcer after endoscopic therapy 40 mg twice daily for 72 hours

Drug: Omeprazole

intravenous omeprazole

ACTIVE COMPARATOR

intravenous omeprazole in bleeding peptic ulcer after endoscopic therapy as continuous infusion at rate of 8 mg/hour for 72 hours

Drug: Omeprazole

Interventions

Omeprazole DRUG

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.

intravenous omeprazole; oral omeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Silverstein FE, Gilbert DA, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. I. Study design and baseline data. Gastrointest Endosc. 1981 May;27(2):73-9. doi: 10.1016/s0016-5107(81)73155-9. No abstract available.

  PMID: 6971775 BACKGROUND

• Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.

  PMID: 7627034 BACKGROUND

• Elwakil R, Reda MA, Abdelhakam SM, Ghoraba DM, Ibrahim WA. Causes and outcome of upper gastrointestinal bleeding in Emergency Endoscopy Unit of Ain Shams University Hospital. J Egypt Soc Parasitol. 2011 Aug;41(2):455-67.

  PMID: 21980783 BACKGROUND

• Quan S, Frolkis A, Milne K, Molodecky N, Yang H, Dixon E, Ball CG, Myers RP, Ghosh S, Hilsden R, van Zanten SV, Kaplan GG. Upper-gastrointestinal bleeding secondary to peptic ulcer disease: incidence and outcomes. World J Gastroenterol. 2014 Dec 14;20(46):17568-77. doi: 10.3748/wjg.v20.i46.17568.

  PMID: 25516672 BACKGROUND

• Melcarne L, Garcia-Iglesias P, Calvet X. Management of NSAID-associated peptic ulcer disease. Expert Rev Gastroenterol Hepatol. 2016 Jun;10(6):723-33. doi: 10.1586/17474124.2016.1142872. Epub 2016 Mar 2.

  PMID: 26775657 BACKGROUND

• Hwang JH, Fisher DA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Early DS, Evans JA, Fanelli RD, Foley K, Fukami N, Jain R, Jue TL, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha S, Saltzman J, Sharaf R, Shergill AK, Dominitz JA, Cash BD; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of acute non-variceal upper GI bleeding. Gastrointest Endosc. 2012 Jun;75(6):1132-8. doi: 10.1016/j.gie.2012.02.033. No abstract available.

  PMID: 22624808 BACKGROUND

• Marmo R, Rotondano G, Piscopo R, Bianco MA, D'Angella R, Cipolletta L. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol. 2007 Feb;102(2):279-89; quiz 469. doi: 10.1111/j.1572-0241.2006.01023.x.

  PMID: 17311650 BACKGROUND

• Cheng HC, Sheu BS. Intravenous proton pump inhibitors for peptic ulcer bleeding: Clinical benefits and limits. World J Gastrointest Endosc. 2011 Mar 16;3(3):49-56. doi: 10.4253/wjge.v3.i3.49.

  PMID: 21455342 BACKGROUND

• Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.

  PMID: 19221370 BACKGROUND

• Sachs G, Shin JM, Howden CW. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006 Jun;23 Suppl 2:2-8. doi: 10.1111/j.1365-2036.2006.02943.x.

  PMID: 16700898 BACKGROUND

• Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.

  PMID: 18423628 BACKGROUND

• Barkun AN, Herba K, Adam V, Kennedy W, Fallone CA, Bardou M. The cost-effectiveness of high-dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding. Aliment Pharmacol Ther. 2004 Jul 15;20(2):195-202. doi: 10.1111/j.1365-2036.2004.02035.x.

  PMID: 15233700 BACKGROUND

• Sung JJ, Suen BY, Wu JC, Lau JY, Ching JY, Lee VW, Chiu PW, Tsoi KK, Chan FK. Effects of intravenous and oral esomeprazole in the prevention of recurrent bleeding from peptic ulcers after endoscopic therapy. Am J Gastroenterol. 2014 Jul;109(7):1005-10. doi: 10.1038/ajg.2014.105. Epub 2014 Apr 29.

  PMID: 24777150 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Zeinab Nasr El Din Ahmed, resident doctor

CONTACT

+201021659698; zeinabnasr9@gmail.com

Ahmed Shawkat Abdelmohsen, lecturer

CONTACT

+201028030699; shawkatahmed84@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: comparison between oral and intravenous omeprazole in management of bleeding peptic ulcer

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 25, 2019

Record last verified: 2019-11