Treatment of gut ulcers in patients with low blood count or obscure internal bleeding while using aspirin or anti-inflammatory pain-killers

Phase 1

• Conditions: Small bowel ulcers associated with iron deficiency anaemia or obscure blood loss in patients using aspirin or non-steroidal anti-inflammatory drugs; MedDRA version: 20.0Level: LLTClassification code 10066761Term: Acute anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10057220Term: Acute post haemorrhagic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10002034Term: AnaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.1Level: LLTClassification code 10002083Term: Anaemia- Hypochromic microcytic pictureSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10014816Term: Endoscopy small intestineSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: PTClassification code 10014817Term: Endoscopy small intestine abnormalSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: PTClassification code 10014818Term: Endoscopy small intestine normalSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: PTClassification code 10041133Term: Small intestine ulcerSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2013-003187-31-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Inclusion criteria
•Obscure occult gastrointestinal bleeding:
•Iron deficiency anaemia (ferritin <100 ug/l, hemoglobin [Hb] 7–12 g/dl [female] or 7–13 g/dl [male])
•Normal upper endoscopy and colonoscopy
•Taking low-dose aspirin (75-325m/ day) or NSAIDs
•Drop in haemoglobin, > 2gm/dl, over two measurements taken within 3 months of the screening visit, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Exclusion criteria
Any of the following is regarded as criterion for exclusion from the study:

1.Systemic disease that is unstable at the time of randomisation [unstable vital signs (pulse, blood pressure, respiratory rate, temperature, etc); ongoing non-gastrointestinal investigations; frequent (more than once/ week) modifications to treatment]
2.Upper gastrointestinal lesions: oesophageal varices; erosive oesophagitis; oesophageal stricture; oesophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
3.Colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
4.Pregnancy, lactation, or women of child-bearing potential not using two contraceptive methods, one of which must be highly effective, or planning pregnancy. Women Not of Childbearing Potential” are defined as those women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of Childbearing Potential” are defined as any female who have experienced menarche and do not meet the criteria for Women Not of Childbearing Potential”. Preferred Highly Effective Contraceptive Methods are those with lower use dependency and include implants, injectables, and some intrauterine devices (IUDs). Combined oral contraceptives, sexual abstinence or vasectomised partner (provided that partner is sole sexual partner and that surgical success has been confirmed in the vasectomised partner) may also be used. Other contraception methods such as barrier contraception with our without spermicide may be used in combination with a highly effective method of contraception.
5.Hypotension: systolic blood pressure <100-mm Hg.
6.History of oesophageal, gastric or duodenal surgery, excluding simple closure of an ulcer or vagotomy.
7.Current or historical evidence of any of the following diseases:
a.Zollinger-Ellison syndrome.
b.Primary oesophageal motility disorder(s) ie, achalasia, scleroderma, primary oesophageal spasm.
c.Malabsorption.
8.Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study.
9.Unstable diabetes mellitus (stable diabetes controlled by diet, oral agents or insulin is not an exclusion criterion).
10.Cerebrovascular disease such as cerebral ischaemia, infarction, haemorrhage or embolus as judged by the investigator to interfere with the evaluation of the study.
11.Suspected or confirmed current malignancy, except minor superficial skin disease.
12.Use of any other investigational compound or participation in another clinical trial within the 90 days prior to start of study medication.
13.Need for continuous concomitant therapy with:
a.Warfarin
b.High dose steroids (more than 7.5 mg of prednisolone or its equivalent daily).
c.Cytotoxic drugs with the exception of methotrexate in patients with arthritis
14.Alcohol and/or drug abuse or any condition associated with poor compliance including expected non-cooperation, as judged by the investigator.
15.Previous participation in this study.
16.Contraindications to study drugs, e.g., known or suspected allergy to misoprostol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In cases of iron deficiency anaemia or obscure gastrointestinal bleeding:<br>To assess the efficacy of an off-patent prostaglandin analogue, misoprostol, in healing of small bowel mucosal damage while continuing to take low-dose aspirin and/ or NSAIDs<br>;Secondary Objective: To assess the change in haemoglobin level following the intake of misoprostol in patients with iron deficiency anaemia/ obscure blood loss and small bowel damage induced by low-dose aspirin or NSAIDs;Primary end point(s): Full healing of small bowel mucosal ulcers or erosions [in patients with iron deficiency anaemia or obscure blood loss, using misoprostol and while continuing on their aspirin or NSAIDs] ;Timepoint(s) of evaluation of this end point: Eight weeks post randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (i)Change in blood haemoglobin level<br>(ii)Change in the numbers of mucosal erosions<br>;Timepoint(s) of evaluation of this end point: (i)Change in blood haemoglobin level: 4 and 8 weeks post randomisation<br><br>(ii)Change in the numbers of mucosal erosions: 8 weeks post randomisation