Irritable bowel syndrome (not constipation predominant). MedDRA version: 7.0 Level: PT Classification code 10023003
Conditions
Interventions
Product Name: AGI 003
Product Code: AGI 003
Pharmaceutical Form: Tablet
INN or Proposed INN: R(+) Verapamil
CAS Number: 38176-02-02
Current Sponsor code: AGI 003
Concentration unit: mg milligram(s)
C
Sponsors
AGI Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1) Any evidence of cardiovascular disease or taking of any medication active on the cardiovascular system, apart from stable low dose aspirin ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to determine the efficacy of r-verapamil in the treatment of IBS, based on the patient’s global impression, relief of abdominal discomfort / pain and use of rescue medication. ;Secondary Objective: Secondary efficacy end-points will include: i) The change from baseline in patient’s global severity of illness scale compared to placebo. ii) The change from baseline in severity of gastrointestinal symptoms scale compared to placebo (bloating/distension, stool frequency, urgency, composite of all symptoms). iii) The change from baseline in Bristol Stool Scale compared to placebo. Daily data from the patient global impression, patient severity of illness scale, severity of gastrointestinal symptoms scale, Bristol Stool Scale and the use of rescue medication will be collected for observation purposes. The safety of AGI 003 in doses of 20mg, 40mg and 80mg t.i.d will be evaluated by assessing adverse events, abnormal laboratory values, heart rate and the mean seated and standing diastolic blood pressure compared to placebo.;Primary end point(s): The first primary endpoint is the difference in the percentage of responders between active and placebo based on the patient’s global impression. The second primary endpoint is the difference in the percentage of responders between active and placebo based on the relief of the patient’s abdominal pain/discomfort. The third primary endpoint is the use of rescue medication (loperamide, paracetamol) during the study compared to placebo. | — |
Countries
Lithuania, United Kingdom
Outcome results
None listed