A randomised, double-blind, placebo-controlled study of AGI 001 in the treatment of irritable bowel syndrome.

Phase 1

• Conditions: Irritable Bowel Syndrome; MedDRA version: 6.0Level: PTClassification code 10023003

• Registration Number: EUCTR2004-004230-14-IE
• Lead Sponsor: AGI Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-10
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1)Be aged 18-50 years
2)Have abdominal discomfort or pain on at least 8 days, which need not be consecutive within 8-14 days of the randomisation visit. A patient may be considered for randomisation at any time during the run-in period, provided they have abdominal discomfort or pain on at least 8 days.
3)Fulfil Rome II criteria (modified) for IBS i.e. in the last three months symptoms of abdominal discomfort or pain that has two out of these three features were present often (at least three weeks, at least one day a week):
a.Relieved with defecation; and/or
b.Onset associated with a change in frequency of stool; and/or
c.Onset associated with a change in form (appearance) of stool.
4)Provide signed written informed consent (Attachment 2).
5)Must be able to make entries into a diary on a daily basis.

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

Exclusion Criteria

1)Lactose intolerance, whose lactose intolerance symptoms are not completely or substantially relieved solely by abstaining from dairy products. (Patients with lactose intolerance on a lactose free diet who qualify otherwise, may be enrolled).
2)Celiac disease (diagnosed using either serology or duodenal biopsy).
3)Unexplained fever or weight loss of at least 10 pounds during the last 6 months, or any clinically significant symptoms, e.g. patients with rectal bleeding or a recent change in pattern of bowel habits (unless they have had a pre-screening colonoscopy to eliminate any other diseases of the gastrointestinal tract that might explain the symptoms).
4)Abnormal laboratory tests, positive stool cultures or abnormal proctoscopy / abdominal ultrasound which requires further investigation.
5)Presence of organic disease of the gastrointestinal tract, liver, pancreas, biliary tree (e.g. gastritis, symptomatic gallstones, duodenal ulcer, gastroenteritis, diverticulitis or megacolon) with the exception of haemorrhoids, hiatus hernia and non-symptomatic gallstones.
6)Functional dyspepsia.
7)Any severe or intolerable upper GI symptoms (i.e. early satiety, postprandial fullness, sensation of prolonged digestion, nausea).
8)Greater than one episode of vomiting per week.
9)Acute diverticulitis or a history of greater than one episode of diverticulitis.
10)History of chronic colitis of any aetiology (e.g. ulcerative colitis, Crohn’s disease, collagen vascular disease, ischaemic colitis). A subject with a history of acute self limited colitis can be included if otherwise qualified.
11)Acute (currently active) colitis of any aetiology.
12)History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction.
13)History of cathartic colon or laxative abuse as determined by the Investigator.
14)Moderate, severe or intolerable gastroesophageal reflux disease or heartburn symptoms.
15)Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony.
16)History of gastrointestinal bleeding based on clinical judgement that would interfere with the subject’s safety or with the efficacy assessments of the study, or if the subject has had gastrointestinal bleeding on two or more occasions within six weeks prior to study enrolment (with the exception of blood from haemorrhoids).
17)History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy).
18)History of pathogenic parasites, ova, bacteria or any occult blood in stools which in the opinion of the Investigator may be responsible for GI symptoms (if measured within one month of Visit 1).
19)Antibiotic use within one month prior to Visit 1 (except for prophylactic antibiotics for such conditions as acne, cystitis, UTI’s etc. (must be on a chronic stable dose for > 3 months).
20)Abnormal colonoscopy within the last five years (with the exception of benign polyps, diverticula, haemorrhoids).
21)Any other past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy.
22)Patients with a family history of colorectal cancer should be properly evaluated.
23)Pregnancy or lactation. Women of childbearing potential must maintain effective contraception (See Section 5.4).
2

Study & Design

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