Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer

NCT03675672 | Recruiting Phase 4

• 1 other identifier: NRT_MISO Study
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Peptic Ulcer Disease/GI Bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Recurrent gastrointestinal bleeding

  24 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Misoprostol Oral tablet, 200mcg, QID

Drug: Misoprostol Oral Tablet

Group 2

PLACEBO COMPARATOR

Placebo Oral Tablet, 1 tab, QID

Drug: Placebo Oral Tablet

Interventions

Misoprostol Oral Tablet DRUG

Misoprostol 200mcg

Also known as: Misoprostol

Group 1

Placebo Oral Tablet DRUG

Placebo Tablet

Also known as: Placebo

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital, Shatin

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Grace LH Wong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace LH Wong, MD

CONTACT

3505 3476; wonglaihung@cuhk.edu.hk

Jessica YL Ching, MSc

CONTACT

3505 3524; jessicaching@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: September 18, 2018
• Study Start: June 21, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

HK (1)