Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs
Status:
Completed
Trial end date:
2017-10-11
Target enrollment:
Participant gender:
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