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

Primary Purpose

Chronic Arthritis, Ischemic Heart Disease, Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Misoprostol

Placebo

About this trial

This is an interventional treatment trial for Chronic Arthritis focused on measuring Aspirin, Intestinal bleeding, Misoprostol, NSAIDs, Small intestine, Video capsule endoscopy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital Crosshouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Misoprostol

Placebo

Arm Description

Misoprostol

Placebo

Outcomes

Primary Outcome Measures

Full healing of small bowel mucosal ulcers or erosions in response to misoprostol in users of aspirin or NSAIDs.

Ulcers or smaller lesions (erosions) should totally disappear by the end of the study

Secondary Outcome Measures

Change in the numbers of mucosal ulcers and erosions

Any increase or decrease in the numbers of ulcers and erosions will be measured at the end of the study

Full Information

NCT ID

NCT02202967

First Posted

July 26, 2014

Last Updated

August 12, 2018

Sponsor

NHS Greater Glasgow and Clyde

1. Study Identification

Unique Protocol Identification Number

NCT02202967

Brief Title

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

Acronym

MASTERS

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]

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 7, 2016 (Actual)

Primary Completion Date

October 11, 2017 (Actual)

Study Completion Date

October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Arthritis, Ischemic Heart Disease, Atrial Fibrillation, Anemia, Bleeding

Keywords

Aspirin, Intestinal bleeding, Misoprostol, NSAIDs, Small intestine, Video capsule endoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Misoprostol

Arm Type

Active Comparator

Arm Description

Misoprostol

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Cytotec (R)

Intervention Description

Misoprostol oral tablets/ capsules contain 200 mcg of Misoprostol, a synthetic prostaglandin E1 analog

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Dummy drug

Intervention Description

Placebo contains lactose granules

Primary Outcome Measure Information:

Title

Full healing of small bowel mucosal ulcers or erosions in response to misoprostol in users of aspirin or NSAIDs.

Description

Ulcers or smaller lesions (erosions) should totally disappear by the end of the study

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in the numbers of mucosal ulcers and erosions

Description

Any increase or decrease in the numbers of ulcers and erosions will be measured at the end of the study

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Change in blood haemoglobin level

Description

Any rise or drop in the haemoglobin level will be measured at the end of the study

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maureen Travers, PhD

Organizational Affiliation

NHS Greater Glasgow & Clyde, Scotland

Official's Role

Study Director

Facility Information:

Facility Name

University Hospital Crosshouse

City

Kilmarnock

State/Province

Scotland

ZIP/Postal Code

KA2 0BE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29754836

Citation

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.

Results Reference

result

Links:

URL

http://dx.doi.org/10.1016/S2468-1253(18)30119-5

Description

Taha AS et al. MASTERS Trial.Lancet Gastroenterol Hepatol 2018;3:469-76

Learn more about this trial

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

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