- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675672
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Grace LH Wong, MD
- Phone Number: 3505 3476
- Email: wonglaihung@cuhk.edu.hk
Study Contact Backup
- Name: Jessica YL Ching, MSc
- Phone Number: 3505 3524
- Email: jessicaching@cuhk.edu.hk
Study Locations
-
-
-
Hongkong, Hong Kong
- Recruiting
- Endoscopy Center, Prince of Wales Hospital, Shatin
-
Contact:
- Grace LH Wong, MD
- Email: wonglaihung@cuhk.edu.hk
-
Contact:
- Jessica YL Ching, MSc
- Email: jessicaching@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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 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).
- 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:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Misoprostol Oral tablet, 200mcg, QID
|
Misoprostol 200mcg
Other Names:
|
Placebo Comparator: Group 2
Placebo Oral Tablet, 1 tab, QID
|
Placebo Tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrent gastrointestinal bleeding
Time Frame: 24 months
|
Recurrent gastrointestinal bleeding (both upper and lower gastrointestinal bleeding) as defined according to the clinical criteria stated in primary endpoint
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grace LH Wong, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Misoprostol
Other Study ID Numbers
- NRT_MISO Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Active Peptic Ulcer Disease/GI Bleeding
-
Kyunghee University Medical CenterCompletedActive Peptic Ulcer Disease/GI BleedingKorea, Republic of
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Chinese University of Hong KongNanfang Hospital, Southern Medical UniversityRecruitingProton Pump Inhibitors | Upper GI BleedingChina
-
Singapore General HospitalCompletedBleeding Peptic Ulcers DiseaseSingapore
-
Kaohsiung Veterans General Hospital.Completed
-
AstraZenecaCompleted
-
Chinese University of Hong KongNational Taiwan University Hospital; Okayama University; Tokyo University; Tsuyama... and other collaboratorsCompletedBleeding Peptic UlcerChina
-
Azienda USL ModenaRecruiting
-
Odense University HospitalRegion of Southern DenmarkUnknownBleeding Peptic UlcerDenmark
Clinical Trials on Placebo Oral Tablet
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
EicOsis Human Health Inc.RecruitingHealthy SubjectsNew Zealand
-
Harmony Biosciences, LLCActive, not recruitingMyotonic Dystrophy 1 | Excessive Daytime SleepinessUnited States, Canada
-
Syntrix Biosystems, Inc.National Institute on Drug Abuse (NIDA); DF/Net ResearchCompletedDiabetic Neuropathies | Neuropathic Pain | Pain, ChronicUnited States
-
University of OxfordNovo Nordisk A/SRecruitingDiabetes Mellitus, Type 2United Kingdom
-
Fulcrum TherapeuticsTerminated
-
EicOsis Human Health Inc.CompletedHealthy AdultsUnited States
-
The Mind Research NetworkTerminatedSmoking Cessation | Tobacco Use DisorderUnited States
-
Cara Therapeutics, Inc.CompletedChronic Kidney Diseases | PruritusUnited States
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis CChina