PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

NCT01180179 | Completed Phase 4 DMC

• 1 other identifier: NNH_RCT
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers.

Conditions

Peptic Ulcer

Keywords

H. pylori-negative idiopathic peptic ulcers; Recurrent ulcer bleeding

Outcome Measures

Primary Outcomes (1)

• Recurrent ulcer bleeding

  According to prespecified criteria - hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy. A prespecified interim-analysis is performed on the primary endpoint when all patients have been randomised and have completed the 12 months follow-up. The interim-analysis is performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring committee (DSMC). The DSMC will have unblinded access to all data and will discuss the results of the interim-analysis with the steering committee in a joint meeting. The steering committee decides on the continuation of the trial and will report to the central ethics committee. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P \< 0.001.

  24 months

Secondary Outcomes (1)

• Recurrent ulcer detected by endoscopy at 24-month

  at the 24th month of follow-up

Study Arms (2)

Lansoprazole 30mg once daily

ACTIVE COMPARATOR

Lansoprazole 30mg once daily

Drug: Lansoprazole

Famotidine 40mg once daily

ACTIVE COMPARATOR

Famotidine 40mg once daily

Drug: Famotidine

Interventions

Lansoprazole DRUG

30mg once daily

Lansoprazole 30mg once daily

Famotidine DRUG

40mg once daily

Famotidine 40mg once daily

Eligibility Criteria

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

You may qualify if:

• A history of H. pylori-negative idiopathic peptic ulcers, defined as
• No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization;
• Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and
• No other causes of ulceration identified.
• Endoscopically confirmed ulcer healing
• Age \>18 years old
• Informed consent

You may not qualify if:

• Concomitant steroid or anticoagulant
• Concomitant use of NSAIDs, aspirin or COX2 inhibitors
• Previous gastric surgery
• Requirement of maintenance PPI (e.g. reflux oesophagitis)
• Advanced comorbidity (defined as ASA 4 or above) or active malignancy
• Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study
• Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine.
• Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital, Shatin

Hong Kong, China

Location

Related Publications (1)

• Wong GLH, Lau LHS, Ching JYL, Tse YK, Ling RHY, Wong VWS, Chiu PWY, Lau JYW, Chan FKL. Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial. Gut. 2020 Apr;69(4):652-657. doi: 10.1136/gutjnl-2019-318715. Epub 2019 Jun 22.

  PMID: 31229990 DERIVED

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Lansoprazole; Famotidine

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach 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; Thiazoles; Azoles

Study Officials

• Grace L Wong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 12, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)