12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2016
• Main ID: NCT02320318
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: Menarini Group
• Public title: 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) IRIS-05
• Scientific title: A 12-week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhoea (IBS-D).
• Date of first enrolment: October 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02320318
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Hong Kong, Korea, Republic of, Singapore, Taiwan

Contacts

• Name: Jan F Tack, Prof.
• Affiliation: Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female patients aged 18 years or older.

- Belonging to the Asian race and specifically to the Chinese, Indian and Korean
ethnicity.

- Clinical diagnosis of IBS-D according to the following symptoms, based on Rome III
modular questionnaire criteria:

1. 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:

- improvement with defecation

- onset associated with a change in the frequency of stool

- onset associated with a change in form (appearance) of stool.

2. Symptom-onset at least 6 months prior to diagnosis.

3. 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.

4. 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 a positive family history of
colorectal cancer: Normal results from colonoscopy/flexible sigmoidoscopy performed
within the last 5 years.

- For patients aged 65 years or older: Absence of ischaemic colitis, microscopy colitis
or any other organic gastrointestinal disease as evidenced by the results of a
colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months.

- For women of childbearing potential: Use of a highly effective contraceptive method
with a failure rate <1% per year throughout the entire study period.

- Physical examination without clinically relevant abnormalities during screening.

- No clinically relevant abnormalities in 12-Lead ECG or in laboratory findings.

- Mentally competent, able to give written informed consent, and compliant to undergo
all visits and procedures.

- Unrestricted access to a touch-tone telephone.

- Willingness to refrain from using loperamide within 3 days prior to run-in visit and
during the run-in period.

Additional criteria at randomisation:

- During both weeks of the run-in period:

1. 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.

2. At least one bowel movement on each day.

3. A weekly average of at least 3 bowel movements per day.

4. 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.

5. 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 data entry.

Exclusion Criteria:

- Male gender.

- Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.

- Colonic or major abdominal surgery, any other major abdominal surgery or elective
major surgery planned or expected during the study.

- History of organic GI abnormalities, inflammatory bowel diseases, complicated
diverticulosis, ischaemic colitis, microscopic colitis.

- History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic
gallbladder stone disease in the previous 6 months.

- History of gluten enteropathy or lactose intolerance.

- Current or previous diagnosis of neoplasia.

- History of endometriosis.

- History of positive tests for ova or parasites, or clostridium difficile toxin or
occult blood in the stool in the previous 6 months.

- History of human immunodeficiency virus infection.

- History of major cardiovascular events in the previous 6 months.

- Uncontrolled hypertension, insulin-dependent diabetes mellitus or abnormal thyroid
function.

- Major psychiatric or neurological disorders or unstable medical condition which may
compromise the efficacy and safety assessments.

- Evidence of clinically significant hepatic disease, severe renal insufficiency or
anemia.

- Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2
months.

- Use of prohibited concomitant medication within the previous month such as
antibiotics, antimuscarinic drugs, drugs enhancing GI motility and analgesics.

- Pregnancy or breastfeeding.

- Inability to understand or collaborate throughout the study.

- Participation in other clinical studies in the previous 4 weeks or concomitant
enrollment in a clinical study.

- Any condition that would compromise the well-being of the patient.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome With Diarrhea

Intervention(s)

Drug: Placebo

Drug: Ibodutant 10 mg

Primary Outcome(s)

Weekly response for abdominal pain intensity AND stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). [Time Frame: 12-week]

Secondary Outcome(s)

Weekly Response for relief of overall IBS signs and symptoms over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). [Time Frame: 12-week]

Evaluation of rebound effects [Time Frame: 12-week]

Weekly response for abdominal pain intensity over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). [Time Frame: 12-week]

Weekly response for stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment (6 out of 12 weeks). [Time Frame: 12-week]

Secondary ID(s)

NAK-08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors