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

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ClinicalTrials.gov Identifier: NCT02202967
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Tracking Information
First Submitted Date  ICMJE July 26, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE January 7, 2016
Actual Primary Completion Date October 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2018)
Full healing of small bowel mucosal ulcers or erosions in response to misoprostol in users of aspirin or NSAIDs. [ Time Frame: 8 weeks ]
Ulcers or smaller lesions (erosions) should totally disappear by the end of the study
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
Full healing of small bowel mucosal ulcers or erosions in response to misoprostol in users of aspirin or NSAIDs. [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT02202967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2018)
Change in the numbers of mucosal ulcers and erosions [ Time Frame: 8 weeks ]
Any increase or decrease in the numbers of ulcers and erosions will be measured at the end of the study
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
Change in the numbers of mucosal erosions [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2018)
Change in blood haemoglobin level [ Time Frame: 8 weeks ]
Any rise or drop in the haemoglobin level will be measured at the end of the study
Original Other Pre-specified Outcome Measures
 (submitted: July 28, 2014)
Change in blood haemoglobin level [ Time Frame: 8 weeks ]
 
Descriptive Information
Brief Title  ICMJE Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs
Official Title  ICMJE Misoprostol for the Healing of Small Bowel Ulceration in Patients With Obscure Blood Loss While Taking Low-dose Aspirin or Nonsteroidal Antiinflammatory Drugs [MASTERS Trial]
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Arthritis
  • Ischemic Heart Disease
  • Atrial Fibrillation
  • Anemia
  • Bleeding
Intervention  ICMJE
  • Drug: Misoprostol
    Misoprostol oral tablets/ capsules contain 200 mcg of Misoprostol, a synthetic prostaglandin E1 analog
    Other Name: Cytotec (R)
  • Drug: Placebo
    Placebo contains lactose granules
    Other Name: Dummy drug
Study Arms  ICMJE
  • Active Comparator: Misoprostol
    Misoprostol
    Intervention: Drug: Misoprostol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Taha AS, McCloskey C, McSkimming P, McConnachie A. Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jul;3(7):469-476. doi: 10.1016/S2468-1253(18)30119-5. Epub 2018 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2014)
104
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 11, 2017
Actual Primary Completion Date October 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

Obscure occult gastrointestinal bleeding: presence of one or more of the following:

  • Positive fecal occult blood test within last 3 months
  • Iron deficiency anemia (ferritin <100 ug/l, hemoglobin [Hb] 7-12 g/dl [female] or 7-13 g/dl [male])
  • Drop in haemoglobin, > 2gm/dl from baseline, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy.

Normal/ absence of potentially bleeding lesions on full upper endoscopy and colonoscopy.

Taking low-dose aspirin (75-325m/ day) and/ or NSAIDs

MAIN EXCLUSION CRITERIA:

  • Incomplete upper endoscopy or colonoscopy
  • Systemic disease that is unstable at the time of randomisation (unstable vital signs; ongoing non-gastrointestinal investigations; frequent modifications to treatment)
  • Intake of certain drugs: high-dose steroids (>7.5-mg prednisolone/ day), cytotoxic drugs, or warfarin.
  • Upper gastrointestinal lesions: oesophageal varices; oesophageal stricture; oesophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
  • Colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
  • Women planning pregnancy, pregnant or women of child-bearing potential not using two contraceptive methods, one of which must be highly effective [implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner]
  • Hypotension: systolic blood pressure <100-mm Hg.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02202967
Other Study ID Numbers  ICMJE GN09CA403
2013-003187-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NHS Greater Glasgow and Clyde
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maureen Travers, PhD NHS Greater Glasgow & Clyde, Scotland
PRS Account NHS Greater Glasgow and Clyde
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP