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Prevention study for Active Peptic Ulcer Disease/GI Bleeding
Official title Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
ClinicalTrials.gov ID: NCT03675672
What this study is testing
What is Misoprostol Oral Tablet?
Misoprostol Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for active peptic ulcer disease/gi bleeding.
Also referred to as Misoprostol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Idiopathic gastroduodenal ulcer bleeding is defined as described in our previous studies [12-15]: Gastroduodenal ulcer bleeding is diagnosed based...
- 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)...
You likely can't join if
- Patients will be excluded from the study if they have any of the followings:
- 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
See the full eligibility criteria
- 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...
- 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...
- Patients will be excluded from the study if they have any of the followings:
- 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
- people who are or will be pregnant or lactating
- people who have known hypersensitivity or allergies to any component of misoprostol and lansoprazole.
- Subject who has current or historical evidence of hypergastrinaemia syndrome or other hypersecretory condition.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.