Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Patients with a history of idiopathic gastroduodenal ulcer bleeding face an increased risk of recurrent ulcer gastrointestinal bleeding. Our ongoing clinical trial demonstrates a possible reduced risk of recurrent idiopathic gastroduodenal ulcer bleeding with proton pump inhibitor (PPI), yet there is a significant risk of recurrent ulcer bleeding as PPI may increase the risk of small bowel bleeding. Our preliminary data provide strong plausibility that a combination therapy of misoprostol (MISO) with a PPI reduces the recurrent ulcer bleeding as well as clinical gastrointestinal bleeding. The investigators are going to provide the definitive answer to this important clinical question through a randomised trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Idiopathic gastroduodenal ulcer bleeding is defined as described in our previous studies [12-15]:

Gastroduodenal ulcer bleeding is diagnosed based on:

i. History of symptoms of upper gastrointestinal bleeding with endoscopically proven gastroduodenal ulcers;

Idiopathic ulcer is diagnosed based on:

i. No experience of ulcerogenic agents (e.g. aspirin, NSAIDs), or drugs of an unknown nature including traditional Chinese medicine during the 4 weeks before hospitalization of gastrointestinal bleeding episode; ii. Negative biopsy urease test and absence of H. pylori on histology in the absence of acid suppressive agents; and iii. No other cause of ulceration identified (e.g. hypergastrinaemia, Crohn's disease, cytomegalovirus and herpes infection).

2. Resume hemoglobin level which is same as or higher than the level prior to last ulcer bleeding episode or stable hemoglobin level (drop <2g/dL) within one year prior randomization iii.3. No reported gastroduodenal ulcer or ulcer bleeding from last upper endoscopy 2.4. Aged 18 years old or above. 3.5. Written informed consent obtained. Fingerprint of subject with a witness involved in the consent procedure will be accepted for illiterate subjects.

Exclusion Criteria:

Patients will be excluded from the study if they have any of the followings:

1. Concomitant steroid or anticoagulant

2. Concomitant use of NSAIDs, aspirin or COX2 inhibitors

3. Previous gastric surgery

4. Requirement of maintenance PPI (e.g. reflux esophagitis)

5. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) or active malignancy

6. Subjects who are or will be pregnant or lactating

7. Subjects who have known hypersensitivity or allergies to any component of misoprostol and lansoprazole.

8. Subject who has current or historical evidence of hypergastrinaemia syndrome or other hypersecretory condition.