A Clinical study assessing the treatment with ibodutant for Irritable Bowel Syndrome with diarrhoea.
- Conditions
- Irritable bowel syndrome with diarrhoea (IBS-D) in female patients.MedDRA version: 17.0Level: LLTClassification code 10060849Term: Diarrhoea predominant irritable bowel syndromeSystem Organ Class: 100000004856MedDRA version: 17.0Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndromeSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-000895-14-GB
- Lead Sponsor
- Menarini Ricerche S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 500
- Female patients aged 18 years or older.
- 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.
- For patients older than 50 years OR patients with positive family
history of colorectal cancer: normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before the start of the Screening period.
- For patients aged 65 years or older: absence of ischaemic colitis, microscopic colitis, or any other organic gastrointestinal (GI) disease as evidenced by the results of a colonoscopy/ flexible sigmoidoscopy with biopsy performed within 6 months before the start of the Screening period.
- Patient willing to refrain from using any anti-diarrhoeal loperamide within 3 days prior to the Run-in visit and during the Run-in period (to be re-checked prior to randomisation).
At the end of Run in period, ONLY patients meeting the following e-diary criteria and all the other inclusion criteria will be eligible to progress to randomisation:
- Patient has during both weeks of the Run-in period a weekly average of worst abdominal pain in the past 24 hours with a score of = 3.0 on a 0 to 10 point scale (Abdominal Pain Intensity).
- Patient has during both weeks of the Run-in period at least one bowel movement on each day.
- Patient has during both weeks of the Run-in period a weekly average of at least 3 bowel movements per day.
- Patient has during both weeks of the Run-in period at least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week (Stool Consistency).
- Patient has during both weeks of the Run-in period less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
- Adequate compliance with the e-diary recording procedure defined as at least 11 of 14 days (=75%) of the nominal daily entry considering the last consecutive 14 days prior the randomisation [NOTE: Run-in duration is 14 days (+3 days)].
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
NOTE: Patient with any alarm signs (e.g. fever, rectal bleeding other than haemorrhoids, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
- Male gender.
- Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria.
- Patient has had surgery that meets any of the following criteria:
a) Colonic or major abdominal surgery, i.e. bariatric surgery and stomach, small/large bowel or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery).
b) Any other major abdominal surgery in the previous 6 months.
-Patient has any elective major surgery planned or expected at any time during the study.
- Patient has a history of inflammatory bowel diseases, complicated diverticulosis (i.e. diverticulitis), ischaemic colitis, microscopic colitis.
- Patient has a history of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, faecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g. aortoiliac disease).
- Patient has a history of pancreatitis of any aetiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
- Patient has an active biliary duct disease or a history of Sphincter of Oddi dysfunction.
- Patient has a history of gluten enteropathy.
- Patient has a history of lactose intolerance as assessed by response to diet.
- Patient has a current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission = 5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
- Patient has a history of ectopic endometriosis.
- Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
- Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. NOTE: dietary habits, lifestyle and exercise regimen should be maintained for the duration of the study.
- Use of prohibited concurrent medication within the previous month, namely: Antibiotics (4 months in the case of rifaximin); 5-HT3 antagonist alosetron.
- Use of prohibited concurrent medication within the previous 7 days, namely (for details see protocol): Antimuscarinic drugs, Drugs enhancing GI motility, Analgesic drugs, Fibre products and herbal preparations, Antidepressants, Benzodiazepines
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