A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AGI 003 IN THE TREATMENT OF NON-CONSTIPATION PREDOMINANT IRRITABLE BOWEL SYNDROME.
- Conditions
- Irritable bowel syndrome (not constipation predominant).MedDRA version: 7.0Level: PTClassification code 10023003
- Registration Number
- EUCTR2004-002752-34-GB
- Lead Sponsor
- AGI Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
All patients must:
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.
And
None of the following symptoms:
a. Fewer than three bowel movements a week;
b. Straining during a bowel movement.
4) Provide signed written informed consent (Attachment 2).
5) Must be able to make entries into a touch tone telephone diary on a daily basis.
6) Must be willing to abstain from taking rescue medication in the run-in phase.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
1) Any evidence of cardiovascular disease or taking of any medication active on the cardiovascular system, apart from stable low dose aspirin (< 75 mg orally/day) for prophylaxis.
2) 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).
3) Celiac disease (Blood test to measure levels of antibodies (antigliadin, anti-endomysium, and antireticulin) to gluten).
4) 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).
5) Abnormal laboratory tests, positive stool cultures or abnormal proctoscopy / abdominal ultrasound which requires further investigation.
6) 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.
7) Functional dyspepsia.
8) Any severe or intolerable upper GI symptoms (i.e. early satiety, postprandial fullness, sensation of prolonged digestion, nausea).
9) Greater than one episode of vomiting per week.
10) Moderate or severe diverticulosis, in the opinion of the Investigator.
11) Acute diverticulosis or a history of greater than one episode of diverticulosis.
12) 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.
13) Acute (currently active) colitis of any aetiology.
14) History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction.
15) History of laxative abuse as determined by the Investigator.
16) Moderate, severe or intolerable gastroesophageal reflux disease or heartburn symptoms.
17) Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony.
18) 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).
19) History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy).
20) Presence 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).
21) 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).
22) Abnormal colonoscopy within the last five years (with the exception of mild benign polyps, mild diverticula, haemorrhoids).
23) Any other past or present disease likely to co
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method