Misoprostol for healing of small bowel ulcers in aspirin & NSAID users

• Research type

  Research Study

• Full title

  Misoprostol for the Healing of Small Bowel Ulceration in Patients with Obscure Blood Loss while Taking Low-Dose Aspirin or Non-Steroidal Anti-inflammatory Drugs [MASTERS Trial]

• IRAS ID

  92246

• Contact name

  Ali S. Taha

• Contact email

  Dr.Taha@aaaht.scot.nhs.uk

• Sponsor organisation

  NHS Greater Glasgow & Clyde,Research and Development Management Office

• Eudract number

  2013-003187-31

• Clinicaltrials.gov Identifier

  NCT02202967

• Research summary

  Background: Given the rising numbers of patients with internal bleeding while using aspirin and anti-inflammatory drugs [NSAIDs], we assume that small bowel ulcers may be healed with misporostol, an off-patent drug that can help regenerate the mucosal lining.
  Aims: To assess the benefit of misoprostol in healing of small bowel ulcers while continuing to take aspirin and anti-inflammatory drugs.

  Design: An 8-week comparison of a dummy pill [placebo] with misoprostol, in the healing of small bowel ulcers diagnosed by a video capsule that is swallowed by aspirin/NSAID users presenting with low blood count due to blood loss.
  Main procedure: video-capsule endoscopy of the small bowel at the beginning [baseline] and 8 weeks after being enrolled to take misoprostol or placebo.

  Main outcome measure: Full healing of ulcers of the small bowel lining.
  Other outcome measures: (i) Change in the numbers of tiny ulcers; (ii) Change in blood count level; (iii) Abdmoinal complaints

  Informed consent will be taken from all participants

  Main health and economic benefits: Reduce blood transfusion requirements; Reduce inpatient stay in hospital; Maintain the therapeutic benefits of low-dose aspirin and NSAIDs; Potential for new treatments and for refinement of video capsule imaging of the small bowel

  Expertise available: The principal applicant has an established record in investigating gut damage and repair in users of aspirin and NSAIDs. The Robertson Centre for Biostatistics manages a full range of trials.
  

• REC name

  West of Scotland REC 1

• REC reference

  14/WS/1084

• Date of REC Opinion

  13 Oct 2014

• REC opinion

  Further Information Favourable Opinion