NCT03675672 Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
| NCT ID | NCT03675672 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Active Peptic Ulcer Disease/GI Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2018-06-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 154 participants in total. It began in 2018-06-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Grace LH Wong, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT03675672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Active Peptic Ulcer Disease/GI Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03675672 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03675672 currently recruiting?
Yes, NCT03675672 is actively recruiting participants. Contact the research team at wonglaihung@cuhk.edu.hk for enrollment information.
Where is the NCT03675672 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT03675672 clinical trial?
NCT03675672 is sponsored by Chinese University of Hong Kong. The principal investigator is Grace LH Wong, MD at Chinese University of Hong Kong. The trial plans to enroll 154 participants.