Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs

Phase 3

Completed

• Conditions: Bleeding; Atrial Fibrillation; Chronic Arthritis; Ischemic Heart Disease; Anemia
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT02202967
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many patients in order to prevent blood clots. Despite their desired benefits, these medicines can cause internal bleeding from the digestive system. The source of this bleeding can be obvious (overt), or obscure and thought to come from the small intestine. Obscure bleeding can show as anemia due to lack of iron in the blood. Small intestine ulcers are now easily diagnosed using an endoscope the size of a big pill (video capsule endoscopy). Small bowel ulcers are not related to stomach acid and therefore do not heal using remedies usually taken to stop acid formation. A different drug, misoprostol, consists of a chemical (prostaglandin) that is usually lacking in patients using aspirin or anti-inflammatory drugs. Misoprostol is licenced to heal stomach and duodenal ulcers in patients using these drugs. Our hypothesis is that misoprostol might be effective in healing small bowel ulcers as suggested by pilot studies; however, such works only included small numbers of patients, did not include control groups and both patients and investigators knew the nature of the tablets used. To test this hypothesis, we propose to compare misoprostol to a dummy tablet. The numbers of subjects to be studied have been calculated using established statistical methods

Detailed Description

METHODOLOGY:

* Upper gastrointestinal endoscopy and colonoscopy on patients with obscure bleeding and/ or iron deficiency anemia.

* Video capsule endoscopy on those fulfilling the inclusion criteria

* Randomization to Misoprostol 200 micrograms or placebo, 4 times each day given for 8 weeks to aspirin/ NSAID users with erosive small bowel lesions.

* Video capsule endoscopy at 8 weeks to check healing of small bowel lesions.

* Full blood count at baseline and monthly intervals (0, 4, and 8 weeks)

Study Timeline

• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Study Start: 2016-01-07
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Misoprostol	Misoprostol	Misoprostol

Primary Outcome Measures

Name	Time	Method
Full healing of small bowel mucosal ulcers or erosions in response to misoprostol in users of aspirin or NSAIDs.	8 weeks	Ulcers or smaller lesions (erosions) should totally disappear by the end of the study

Secondary Outcome Measures

Name	Time	Method
Change in the numbers of mucosal ulcers and erosions	8 weeks	Any increase or decrease in the numbers of ulcers and erosions will be measured at the end of the study

Trial Locations

Locations (1)

University Hospital Crosshouse; 🇬🇧 Kilmarnock, Scotland, United Kingdom