Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

Launched by CHINESE UNIVERSITY OF HONG KONG · Sep 14, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating how to prevent recurrent bleeding from ulcers in the stomach and upper part of the small intestine, specifically in patients who have experienced this type of bleeding without an obvious cause. The researchers are looking at whether a combination of two medications—a proton pump inhibitor (PPI), which helps reduce stomach acid, and misoprostol (MISO), which protects the stomach lining—can lower the chances of bleeding again. The study is currently recruiting participants aged 18 and older who have had ulcer bleeding but are not currently using certain pain medications or have other specific medical issues.

Eligible participants can expect to receive close monitoring and treatment during the trial. They will need to provide written consent to join the study, and those participating will help determine if this combination therapy is effective in preventing future ulcer bleeding. This research is important because it aims to find a safer and more effective way to protect patients who are at risk for recurrent ulcer-related complications.

Gender

ALL

Eligibility 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 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.