Irritable Bowel Syndrome with Diarrhea (IBS-D) MedDRA version: 9.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome
Conditions
Sponsors
AGI Therapeutics Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients, 18 to 75 years of age inclusive, meeting ROME III criteria for IBS-D, and free of any cardiac contraindication to verapamil and who meet all the of the following inclusion/exclusion criteria. Inclusion Criteria: 1) Are aged 18 to 75 years, inclusive, at the time of entry into the Clin-AGI003-003 study. 2) Have completed the Clin-AGI003-003 study. 3) Provide signed written informed consent. 4) Must be willing to abstain from eating grapefruit or drinking grapefruit juice for duration of the study 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Not completed the Clin-AGI003-003 study. 2) Any evidence of cardiovascular disease or any other disease where treatment with verapamil is contra-indicated such as: • Severe left ventricular dysfunction • Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock • Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) • Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) • Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (eg, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). 3) Lactose intolerance as reported by the patient and patient is not currently abstaining from milk products or not taking lactase enzyme OTC products and for the duration of the study will not agree to continuing to abstain or will not agree to continue their OTC medication. 4) Coeliac disease (diagnosed using either serology or duodenal biopsy). 5) Unexplained fever or weight loss of at least 10 pounds during the last 6 months, or any clinically significant symptoms (e.g., 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). 6) Abnormal screening lab tests assessed as clinically significant by the Investigator, or within 3 months of the screening visit have had a positive stool cultures or abnormal proctoscopy/abdominal ultrasound requiring further investigation 7) Presence of ongoing 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 8) Prior gastroparesis diagnosis by a physician 9) Barrett’s and/or Grade III esophagitis 10) Greater than one episode of vomiting per week within a month prior to screening 11) Acute diverticulitis or a history of greater than one episode of diverticulitis 12) History of chronic colitis or acute self-limiting colitis of any etiology within 5years of the screening visit (e.g. ulcerative colitis, Crohn’s disease, collagen vascular disease, ischemic colitis, enteric infection). 13) History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction, gastric banding or bariatric surgery 14) History of laxative abuse as determined by the Investigator 15) Gastroesophageal reflux disease that is not controlled by the use of stable doses of PPIs for at least 3 months prior to the screening visit 16) Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony 17) 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) 18) History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy) 19) Presence of pathogenic parasites, ova, bacteria or any occult blood in stools which in the opinion of the Investigator may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to determine the long-term safety of AGI-003 (arverapamil) in the treatment of IBS-D.;Secondary Objective: ;Primary end point(s): Safety: The safety assessments will include AEs, laboratory values (hematology and chemistry), 12-lead ECG, manual blood pressure (seated and standing) and heart rate. | — |
Countries
Belgium, Czech Republic, Lithuania, Poland
Outcome results
None listed