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Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

Primary Purpose

Active Peptic Ulcer Disease/GI Bleeding

Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Misoprostol Oral Tablet
Placebo Oral Tablet
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Active Peptic Ulcer Disease/GI Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Endoscopy Center, Prince of Wales Hospital, ShatinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Misoprostol Oral tablet, 200mcg, QID

Placebo Oral Tablet, 1 tab, QID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrent gastrointestinal bleeding
Recurrent gastrointestinal bleeding (both upper and lower gastrointestinal bleeding) as defined according to the clinical criteria stated in primary endpoint

Full Information

First Posted
May 28, 2018
Last Updated
February 3, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03675672
Brief Title
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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. :

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Peptic Ulcer Disease/GI Bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Misoprostol Oral tablet, 200mcg, QID
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Tablet, 1 tab, QID
Intervention Type
Drug
Intervention Name(s)
Misoprostol Oral Tablet
Other Intervention Name(s)
Misoprostol
Intervention Description
Misoprostol 200mcg
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Tablet
Primary Outcome Measure Information:
Title
Recurrent ulcer bleeding
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Recurrent gastrointestinal bleeding
Description
Recurrent gastrointestinal bleeding (both upper and lower gastrointestinal bleeding) as defined according to the clinical criteria stated in primary endpoint
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace LH Wong, MD
Phone
3505 3476
Email
wonglaihung@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica YL Ching, MSc
Phone
3505 3524
Email
jessicaching@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace LH Wong, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital, Shatin
City
Hongkong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace LH Wong, MD
Email
wonglaihung@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Jessica YL Ching, MSc
Email
jessicaching@cuhk.edu.hk

12. IPD Sharing Statement

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Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

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