Status:
COMPLETED
Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Chronic Arthritis
Ischemic Heart Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 pre...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2017
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT02202967
Start Date
January 7 2016
End Date
October 11 2017
Last Update
August 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Crosshouse
Kilmarnock, Scotland, United Kingdom, KA2 0BE