The Efficacy of Double Doses of Oral Esomeprazole in Preventing Rebleeding for Patients With Bleeding Peptic Ulcers

NCT01591083 | Completed Phase 4 DMC

• 1 other identifier: ER-100-008
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with comorbidities have an increased risk of ulcer re-bleeding, especially within the 14 days after first bleeding event. Three-day high dose esomeprazole infusion can prevent peptic ulcer rebleeding after endoscopic therapy. However, the optimal dose of oral esomeprazole is uncertain, especially for high risky patients. This study is to test whether a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with Rockall score ≥ 6. Additionally, the second aim of this prospective study was to identify the selection criteria to predict poor fading and residual major stigmata of recent hemorrhage (SRH) or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI infusion.

Conditions

Peptic Ulcer Bleeding

Keywords

Peptic ulcer rebleeding, double dose of esomeprazole

Outcome Measures

Primary Outcomes (1)

• recurrent bleeding

  within 28 days after the first bleeding event

Secondary Outcomes (5)

• the length of hospitalization

  within 28 days after the first bleeidng event

• the amount of blood transfusion

  within 28 days after the first bleeding event

• major events such as surgery or transarterial embolization

  within 28 days after the first bleeding event

• the fading rate of major stigmata of recent hemorrhage

  within 3 days after the first bleeding event

• mortality

  within 28 days and 120 days after the first bleeding event

Study Arms (3)

Double oral dose

ACTIVE COMPARATOR

Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days.

Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)

Regular oral dose

ACTIVE COMPARATOR

Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole once daily for 25 days.

Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)

Control group

ACTIVE COMPARATOR

Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole once daily for 25 days.

Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)

Interventions

esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) DRUG

Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients with Rockall score \>=6 are randomized into the double oral dose group and the regular oral dose group. Patients with Rockall score \<6 are assigned to the control group. In the double oral dose group, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days. In the other two groups, patients receive 40 mg oral esomeprazole 40 mg once daily for 25 days.

Also known as: Nexium

Control group; Double oral dose; Regular oral dose

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received gastroscopy for melena, hematochezia, or hematemesis in whom bleeding peptic ulcers with major stigmata of recent hemorrhage are detected are consecutively enrolled. All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy.

You may not qualify if:

• Patients are excluded if they had tumor bleeding or ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction), warfarin use, failure to establish hemostasis under gastroscopy, or hypersensitivity to esomeprazole or any component of the formulation.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

Related Publications (3)

• Yang EH, Wu CT, Kuo HY, Chen WY, Sheu BS, Cheng HC. The recurrent bleeding risk of a Forrest IIc lesion at the second-look endoscopy can be indicated by high Rockall scores >/= 6. Surg Endosc. 2020 Apr;34(4):1592-1601. doi: 10.1007/s00464-019-06919-3. Epub 2019 Jun 20.

  PMID: 31222633 DERIVED

• Cheng HC, Yang EH, Wu CT, Wang WL, Chen PJ, Lin MY, Sheu BS. Hypoalbuminemia is a predictor of mortality and rebleeding in peptic ulcer bleeding under proton pump inhibitor use. J Formos Med Assoc. 2018 Apr;117(4):316-325. doi: 10.1016/j.jfma.2017.07.006. Epub 2017 Jul 24.

  PMID: 28751088 DERIVED

• Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.

  PMID: 24658598 DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Omeprazole; 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

• Bor-Shyang Sheu, MD

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 3, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

TW (1)