Double-blind, randomised, placebo-controlled, parallel-group phase II study to evaluate the effect of oral ibodutant in irritable bowel syndrome with diarrhoea (IBS-D) - The Iris-2 Study. - IRIS-2

Menarini Ricerche S.p.A.0 sites1,220 target enrollmentMay 26, 2010

ConditionsIrritable bowel syndrome with diarrhoea (IBS-D)MedDRA version: 14.0Level: LLTClassification code 10060849Term: Diarrhoea predominant irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Irritable bowel syndrome with diarrhoea (IBS-D)
Sponsor: Menarini Ricerche S.p.A.
Enrollment: 1220
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 26, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Menarini Ricerche S.p.A.

Eligibility Criteria

Inclusion Criteria

•Patients meeting the following criteria will be eligible for entry into the study and start the run\-in period:
•1\. Male or female patients aged 18 \- 70 years with a clinical diagnosis of IBS\-D according to the following symptom\-based criteria as per Rome III modular questionnaire criteria:
•\- Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
•\- Symptom\-onset at least 6 months prior to diagnosis.
•\- Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
•\- Additional criterion: More than 3 bowel movements per day at least 25% of the time in the last 3 months.
•2\. Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before Screening (Day \-14\).
•3\. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
•4\. For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate \<1% per year throughout the entire study period and up to 30 days post\-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous 6 months.
•5\. Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria

•Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:
•1\. Organic abnormalities of the GI tract, including history of colonic or major abdominal surgery, i.e. stomach, small/large bowel, or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery), current or previous diagnosis of neoplasia (except non\-GI neoplasia in complete remission \= 5 years), inflammatory bowel diseases, symptomatic gallbladder stone disease, complicated diverticulosis (i.e. diverticulitis), ectopic endometriosis.
•NOTE: Patients with alarm signs (e.g. fever, rectal bleeding, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
•2\. History of gluten enteropathy.
•3\. Lactose intolerance as assessed by response to diet.
•4\. History of positive tests for ova or parasites, or occult blood in the stool in the previous 6 months.
•5\. Previous diagnosis of diabetes mellitus (either type 1 or 2\).
•6\. Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable for at least the last 2 months.
•7\. Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
•8\. Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.