Active Peptic Ulcer Disease/GI BleedingPhase 4NCT03675672
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
A Phase 4 study testing Misoprostol Oral Tablet in people with Active Peptic Ulcer Disease/GI Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Peptic Ulcer Disease/GI Bleeding
- What is being tested?
- Misoprostol Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jun 2018to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic gastroduodenal ulcer bleeding is defined as described in our previous studies [12-15]:
- Gastroduodenal ulcer bleeding is diagnosed based on:
- History of symptoms of upper gastrointestinal bleeding with endoscopically proven gastroduodenal ulcers;
- Idiopathic ulcer is diagnosed based on:
- 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).
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Subjects who are or will be pregnant or lactating
- Subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Endoscopy Center, Prince of Wales Hospital, Shatin
Hong Kong
Grace LH Wong, MD, wonglaihung@cuhk.edu.hk
Jessica YL Ching, MSc, jessicaching@cuhk.edu.hk
About this study
Official title: 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)
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.
Read the detailed description
HYPOTHESIS The hypothesis that a combination therapy of misoprostol and lansoprazole is superior to lansoprazole alone for the prevention of recurrent ulcer bleeding in patients with a history of idiopathic ulcer bleeding.
STUDY DESIGN OVERVIEW It is a two-year, double blinded, randomized trial of a combination therapy with misoprostol with PPI (lansoprazole) versus misoprostol placebo plus PPI (lansoprazole) in patients with a history of idiopathic ulcer bleeding.
Randomization All eligible patients will be randomly assigned (in a 1:1 ratio) to receive 24 months of either misoprostol 800 micrograms daily (i.e. misoprostol 200 micrograms four times daily) combined with lansoprazole 30 mg once daily, or misoprostol placebo four times daily plus lansoprazole 30 mg once daily. A computer-generated randomisation schedule is used to assign patients to the treatment sequences. Concealment of allocation will be ascertained by an independent research staff member. The Clinical Research Pharmacy located in Prince of Wales Hospital will dispense consecutively numbered, identical packs that contain sealed bottles of the study medications.
Follow-up assessment After the randomisation visit, patients will return at month 2, month 6, and then every four months thereafter until 24 months (follow up ± 14 days from scheduled clinic visit is allowed). At each visit, we will assess patients' complete blood picture, renal and liver function tests, and serum salicylate level, compliance to study medications, and the use of other medications including over-the-counter drugs, and safety of the treatment. Drug adherence is assessed by counting the study drugs. Patients are permitted to take antacids to relieve dyspepsia. Drugs prohibited during the study include anticoagulant agents, NSAIDs, cyclooxygenase-2 inhibitors, over-the-counter analgesics (including herbal products), misoprostol, sucralfate, antiplatelet drugs, bisphosphonates, and PPIs/H2RAs apart from the study drugs.
:
- Conditions
- Active Peptic Ulcer Disease/GI Bleeding
- Being tested
- Misoprostol Oral Tablet, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Oral TabletDrug
Also called Misoprostol
Misoprostol 200mcg
Placebo Oral TabletDrug
Also called Placebo
Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Misoprostol Oral tablet, 200mcg, QID Receives: Drug: Misoprostol Oral Tablet |
| Group 2 | Placebo comparator | Placebo Oral Tablet, 1 tab, QID Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ulcer bleeding
Recurrent ulcer bleeding confirmed endoscopically. Clinical gastrointestinal bleeding is as defined as haematemesis, per-rectal bleeding and/or melena confirmed and documented by the attending doctor, or a drop in haemoglobin level of 2 g/dL from baseline or more. An ulcer is defined as a circumscribed mucosal break at least 5 mm in the largest diameter and with an observable depth. Bleeding erosion is defined as a break in gastric or duodenal mucosa of any size with the co-existence of blood in the upper gastrointestinal tract.
Measured: 24 months
Secondary outcomes (1)
Recurrent gastrointestinal bleeding
Recurrent gastrointestinal bleeding (both upper and lower gastrointestinal bleeding) as defined according to the clinical criteria stated in primary endpoint
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start21 Jun 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Peptic Ulcer Disease/GI BleedingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lai Hung Wong, Chinese University of Hong Kong
- Investigators
- Grace LH Wong, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675672
- Sponsor's protocol ID
- NRT_MISO Study
- Status last verified
- Feb 2024
- First submitted
- 28 May 2018
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03675672
- Acronym / sponsor ID
- NRT_MISO Study
- Conditions
- Active Peptic Ulcer Disease/GI Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESIS The hypothesis that a combination therapy of misoprostol and lansoprazole is superior to lansoprazole alone for the prevention of recurrent ulcer bleeding in patients with a history of idiopathic ulcer bleeding.
STUDY DESIGN OVERVIEW It is a two-year, double blinded, randomized trial of a combination therapy with misoprostol with PPI (lansoprazole) versus misoprostol placebo plus PPI (lansoprazole) in patients with a history of idiopathic ulcer bleeding.
Randomization All eligible patients will be randomly assigned (in a 1:1 ratio) to receive 24 months of either misoprostol 800 micrograms daily (i.e. misoprostol 200 micrograms four times daily) combined with lansoprazole 30 mg once daily, or misoprostol placebo four times daily plus lansoprazole 30 mg once daily. A computer-generated randomisation schedule is used to assign patients to the treatment sequences. Concealment of allocation will be ascertained by an independent research staff member. The Clinical Research Pharmacy located in Prince of Wales Hospital will dispense consecutively numbered, identical packs that contain sealed bottles of the study medications.
Follow-up assessment After the randomisation visit, patients will return at month 2, month 6, and then every four months thereafter until 24 months (follow up ± 14 days from scheduled clinic visit is allowed). At each visit, we will assess patients' complete blood picture, renal and liver function tests, and serum salicylate level, compliance to study medications, and the use of other medications including over-the-counter drugs, and safety of the treatment. Drug adherence is assessed by counting the study drugs. Patients are permitted to take antacids to relieve dyspepsia. Drugs prohibited during the study include anticoagulant agents, NSAIDs, cyclooxygenase-2 inhibitors, over-the-counter analgesics (including herbal products), misoprostol, sucralfate, antiplatelet drugs, bisphosphonates, and PPIs/H2RAs apart from the study drugs.
:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Misoprostol Oral TabletMisoprostol Oral tablet, 200mcg, QID |
| Group 2 | Placebo comparator | Drug: Placebo Oral TabletPlacebo Oral Tablet, 1 tab, QID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol Oral TabletAlso: MisoprostolMisoprostol 200mcg | Drug | Group 1 |
| Placebo Oral TabletAlso: PlaceboPlacebo Tablet | Drug | Group 2 |
Primary outcome
Recurrent ulcer bleeding
Time frame: 24 months
Recurrent ulcer bleeding confirmed endoscopically. Clinical gastrointestinal bleeding is as defined as haematemesis, per-rectal bleeding and/or melena confirmed and documented by the attending doctor, or a drop in haemoglobin level of 2 g/dL from baseline or more. An ulcer is defined as a circumscribed mucosal break at least 5 mm in the largest diameter and with an observable depth. Bleeding erosion is defined as a break in gastric or duodenal mucosa of any size with the co-existence of blood in the upper gastrointestinal tract.
1 secondary outcome
Recurrent gastrointestinal bleeding
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace LH Wong, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol Oral Tablet in people with Active Peptic Ulcer Disease/GI Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace LH Wong, MD (3505 3476, wonglaihung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ulcer bleeding (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.