Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

NCT02536989 | Completed Phase 4 DMC

• 1 other identifier: FEMH-96-C009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.

Conditions

Peptic Ulcer; Hemorrhage

Keywords

peptic ulcer bleeding; blood clot; dose

Outcome Measures

Primary Outcomes (1)

• rebleeding rate within 30 days after allocation

  within 30 days after allocation

Secondary Outcomes (1)

• blood transfusion units needed within 30 days after allocation

  within 30 days after allocation

Study Arms (2)

1

EXPERIMENTAL

receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days

Drug: omeprazole

2

ACTIVE COMPARATOR

receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days

Drug: omeprazole

Interventions

omeprazole DRUG

receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days

Also known as: Losec, iv, high dose

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 22050, Taiwan

Location

Related Publications (17)

• Martins NB, Wassef W. Upper gastrointestinal bleeding. Curr Opin Gastroenterol. 2006 Nov;22(6):612-9. doi: 10.1097/01.mog.0000245542.95408.5d.

  PMID: 17053438 BACKGROUND

• Rollhauser C, Fleischer DE. Nonvariceal upper gastrointestinal bleeding. Endoscopy. 2004 Jan;36(1):52-8. doi: 10.1055/s-2004-814114.

  PMID: 14722856 BACKGROUND

• Jung HK, Son HY, Jung SA, Yi SY, Yoo K, Kim DY, Moon IH, Lee HC. Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots. Am J Gastroenterol. 2002 Jul;97(7):1736-40. doi: 10.1111/j.1572-0241.2002.05780.x.

  PMID: 12135028 BACKGROUND

• Bleau BL, Gostout CJ, Sherman KE, Shaw MJ, Harford WV, Keate RF, Bracy WP, Fleischer DE. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc. 2002 Jul;56(1):1-6. doi: 10.1067/mge.2002.125365.

  PMID: 12085028 BACKGROUND

• Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC. The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med. 2003 Aug 19;139(4):237-43. doi: 10.7326/0003-4819-139-4-200308190-00005.

  PMID: 12965978 BACKGROUND

• Sheu BS, Chi CH, Huang CC, Kao AW, Wang YL, Yang HB. Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2002 Jan;16(1):137-43. doi: 10.1046/j.1365-2036.2002.01137.x.

  PMID: 11856088 BACKGROUND

• Lin HJ, Lo WC, Cheng YC, Perng CL. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Am J Gastroenterol. 2006 Mar;101(3):500-5. doi: 10.1111/j.1572-0241.2006.00399.x.

  PMID: 16542286 BACKGROUND

• Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.

  PMID: 17442905 BACKGROUND

• Swain CP, Kirkham JS, Salmon PR, Bown SG, Northfield TC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet. 1986 May 17;1(8490):1113-7. doi: 10.1016/s0140-6736(86)91835-0.

  PMID: 2871378 BACKGROUND

• Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G, Imperiale TF. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 2005 Sep;129(3):855-62. doi: 10.1053/j.gastro.2005.06.070.

  PMID: 16143125 BACKGROUND

• Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. doi: 10.1053/gast.2002.34782.

  PMID: 12145792 BACKGROUND

• Laine L, Freeman M, Cohen H. Lack of uniformity in evaluation of endoscopic prognostic features of bleeding ulcers. Gastrointest Endosc. 1994 Jul-Aug;40(4):411-7. doi: 10.1016/s0016-5107(94)70202-0.

  PMID: 7926529 BACKGROUND

• Lau JY, Sung JJ, Chan AC, Lai GW, Lau JT, Ng EK, Chung SC, Li AK. Stigmata of hemorrhage in bleeding peptic ulcers: an interobserver agreement study among international experts. Gastrointest Endosc. 1997 Jul;46(1):33-6. doi: 10.1016/s0016-5107(97)70206-2.

  PMID: 9260702 BACKGROUND

• Swain CP, Storey DW, Bown SG, Heath J, Mills TN, Salmon PR, Northfield TC, Kirkham JS, O'Sullivan JP. Nature of the bleeding vessel in recurrently bleeding gastric ulcers. Gastroenterology. 1986 Mar;90(3):595-608. doi: 10.1016/0016-5085(86)91113-3.

  PMID: 3943691 BACKGROUND

• Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.

  PMID: 8058080 BACKGROUND

• Katschinski B, Logan R, Davies J, Faulkner G, Pearson J, Langman M. Prognostic factors in upper gastrointestinal bleeding. Dig Dis Sci. 1994 Apr;39(4):706-12. doi: 10.1007/BF02087411.

  PMID: 7908623 BACKGROUND

• Consensus conference: Therapeutic endoscopy and bleeding ulcers. JAMA. 1989 Sep 8;262(10):1369-72. No abstract available.

  PMID: 2668576 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer; Hemorrhage; Peptic Ulcer Hemorrhage; Thrombosis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

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

Study Officials

• Tzong-Hsi Lee, M.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: September 1, 2015
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 8, 2016

Record last verified: 2010-08

Locations

TW (1)