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, willing to abstain from taking rescue medication in the run in phase, and free of any cardiac contraindication to verapamil and who meet all the of the following inclusion/exclusion criteria. 1) Age 18-75 years 2) Fulfil ROME III criteria for IBS-D and at screening report their usual abdominal pain /discomfort score at no greater than 4 on the scale of 1-6. 3) Provide signed written informed consent 4) Must be able to make entries into a touch tone telephone diary on a daily basis 5) Must be willing to abstain from taking rescue medication in the run-in phase 6) Must be willing to abstain from eating grapefruit or drinking grapefruit juice for the treatment phase of the study If the patient meets the above criteria, then the criteria for randomization after the run-in period are the following: 1) Be compliant in the use of IVRS for at least 11 of the run-in days. 2) Has typical bowel movements on a minimum of 7 days and at least 50% of the run-in period days, e.g. 8 of 15 days reported as 5, 6 or 7 on the BSS with the IVRS. 3) Has abdominal discomfort or pain on a minimum of 7 days and at least 50% of the run-in period days, which need not be consecutive. For the days when they report on IVRS their average pain score must be 0.5-4.0 on the pain scale. 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) During screening the patient reports their usual abdominal pain/discomfort score is 5 or 6 on a scale of 1-6 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 1 episode of vomiting per week within a month prior to screening 11) Acute diverticulitis or a history of greater than 1 episode of diverticulitis 12) History of chronic colitis or acute self-limiting colitis of any etiology within 5 years 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 2 or more occasions within 6 weeks prior to study enrolment (except 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 be responsible for G
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to determine the efficacy and safety of AGI-003 (arverapamil) in the treatment of IBS-D during an active phase of diarrhea based on the patient’s global impression of adequate relief.;Secondary Objective: Change from base line of symptoms associated with IBS-D;Primary end point(s): The primary efficacy endpoint is the Global Impression Treatment Response from Day 1 through Day 56. Only patients who answer ‘yes’ to the following question (defined as Global Impression) at least 50% of the days (i.e., at least 28 out of the 56 days) will be classified as a responder - “Today, do you consider that you had adequate relief from your IBS symptoms?” | — |
Countries
Belgium, Czech Republic, Lithuania
Outcome results
None listed