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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

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

Condition or disease Intervention/treatment Phase
Chronic Arthritis Ischemic Heart Disease Atrial Fibrillation Anemia Bleeding Drug: Misoprostol Drug: Placebo Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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]
Actual Study Start Date : January 7, 2016
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Misoprostol
Misoprostol
Drug: Misoprostol
Misoprostol oral tablets/ capsules contain 200 mcg of Misoprostol, a synthetic prostaglandin E1 analog
Other Name: Cytotec (R)

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo contains lactose granules
Other Name: Dummy drug




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202967


Locations
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United Kingdom
University Hospital Crosshouse
Kilmarnock, Scotland, United Kingdom, KA2 0BE
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
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Study Director: Maureen Travers, PhD NHS Greater Glasgow & Clyde, Scotland

Additional Information:
Publications of Results:
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02202967     History of Changes
Other Study ID Numbers: GN09CA403
2013-003187-31 ( EudraCT Number )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by NHS Greater Glasgow and Clyde:
Aspirin
Intestinal bleeding
Misoprostol
NSAIDs
Small intestine
Video capsule endoscopy
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Hemorrhage
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Misoprostol
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Abortifacient Agents, Nonsteroidal