Preventing recurrent ulcer bleeding in patients with idiopathic ulcers

Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer: a Double-blind Randomised Trial on Misoprostol Combined With Lansoprazole Versus Lansoprazole Alone (NRT_MISO Study)

This study is testing if a combination of misoprostol and lansoprazole can better prevent bleeding from stomach ulcers in people who have had this problem before, compared to just taking lansoprazole alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT03675672 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether a combination therapy of misoprostol and lansoprazole is more effective than lansoprazole alone in preventing recurrent gastrointestinal bleeding in patients with a history of idiopathic gastroduodenal ulcer bleeding. The study is a two-year, double-blinded, randomized trial where participants will receive either the combination therapy or a placebo alongside lansoprazole. Patients will be monitored through regular follow-up visits to assess their health and treatment efficacy. The goal is to provide definitive evidence on the effectiveness of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are patients with a history of idiopathic gastroduodenal ulcer bleeding who meet specific inclusion criteria.

Not a fit: Patients with known ulcerogenic agents or other identifiable causes of ulceration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of recurrent ulcer bleeding in patients with idiopathic ulcers.

How similar studies have performed: Other studies have suggested the potential benefits of combination therapies for ulcer prevention, but this specific approach is novel.

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.

Where this trial is running

Hong Kong

• Endoscopy Center, Prince of Wales Hospital, Shatin — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Grace LH Wong, MD — Chinese University of Hong Kong
• Study coordinator: Grace LH Wong, MD

Conditions Active Peptic Ulcer Disease/GI Bleeding