Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer (NCT03675672) | Clinical Trial Compass
RecruitingPhase 4
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
Hong Kong154 participantsStarted 2018-06-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Idiopathic gastroduodenal ulcer bleeding is defined as described in our previous studies \[12-15\]:
✓. 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
✕. Concomitant anticoagulant
✕. Concomitant use of NSAIDs, aspirin or COX2 inhibitors
✕. Previous gastric surgery
✕. Requirement of maintenance PPI (e.g. reflux esophagitis)
✕. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) or active malignancy
✕. Subjects who are or will be pregnant or lactating