Actively Recruiting
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
Led by Chinese University of Hong Kong · Updated on 2024-02-07
154
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of idiopathic gastroduodenal ulcer bleeding confirmed by symptoms and endoscopy
- No use of ulcer-causing drugs like aspirin, NSAIDs, or unknown traditional medicines in the 4 weeks before bleeding episode
- Negative tests for H. pylori infection without acid suppressive agents
- No other known cause of ulceration such as hypergastrinaemia or infections
- Stable or improved hemoglobin level compared to before last ulcer bleeding, with less than 2g/dL drop in past year
- No active gastroduodenal ulcer or bleeding on last endoscopy
- Age 18 years or older
- Written informed consent obtained
You will not qualify if you...
- Use of anticoagulants
- Use of NSAIDs, aspirin, or COX2 inhibitors
- Previous gastric surgery
- Need for ongoing proton pump inhibitor treatment
- Severe other illnesses (e.g., advanced comorbidity grade 4 or higher) or active cancer
- Pregnant or breastfeeding women
- Known allergies to misoprostol or lansoprazole
- Current or past hypergastrinaemia syndrome or other excessive acid secretion conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Endoscopy Center, Prince of Wales Hospital, Shatin
Hong Kong, Hong Kong
Actively Recruiting
Research Team
G
Grace LH Wong, MD
CONTACT
J
Jessica YL Ching, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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