Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007203

Trial Description

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Title

A 52-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Phase III Study With Re-randomisations at Week 25 to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhoea (IBS-D)

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Trial Acronym

IRIS-4

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder
characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial
aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as
compared to placebo in women with IBS-D over a 24-week treatment period

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Brief Summary in Scientific Language

The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 24
weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and
placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain
intensity and stool consistency over 24 weeks of treatment in at least 50% of the weeks of
treatment.

The clinical phase of the study comprises up to 2 weeks of screening for patient's
eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a first
24-week double-blind treatment period, a second 26-week re-randomised treatment period
period and a 2-week safety follow-up, resulting in a maximum 58-week overall duration of the
study for each patient.

Patients report their IBS-related symptoms daily in a telephone-based electronic diary from
run-in until end of treatment.

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Organizational Data

  •   DRKS00007203
  •   2015/01/09
  •   2014/04/17
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2013-000895-14 
  •   NCT02120027  (ClinicalTrials.gov)
  •   NAK-07  (Menarini Group)
  •   2013-000895-14 
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Health Condition or Problem studied

  •   Irritable Bowel Syndrome With Diarrhea
  •   K58.0 -  Irritable bowel syndrome with diarrhoea
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Interventions/Observational Groups

  •   Drug: Ibodutant 10 mg
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks).; time frame: 24 weeks; The patient will be considered a weekly responder if she meets both of the following criteria in the same week:
Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.

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Secondary Outcome

- Weekly response for abdominal pain intensity over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks).; time frame: 24 weeks; The patient will be considered a weekly abdominal pain responder if she meets the following criterion:
Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.
- Weekly response for stool consistency over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks).; time frame: 24 weeks; The patient will be considered a weekly stool consistency responder is she meets the following criterion:
Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
- Weekly response for relief of overall IBS signs and symptoms over the first 24 weeks of treatment in at least 50% of the weeks (12 out of 24); time frame: 24 weeks; The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to "completely relieved/improved" or "considerably relieved/improved".
- Sustained efficacy; time frame: 24 weeks; Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment applying the 50% rule with at least 2 weeks of response in the last 4 weeks of treatment (week 21 to 24). The patient will be considered a weekly responder as defined for the primary endpoint.

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Countries of Recruitment

  •   United States
  •   Czech Republic
  •   Germany
  •   Hungary
  •   Latvia
  •   Poland
  •   Slovakia
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/03/31
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- At screening:

- Female patients aged 18 years or older.

- Clinical diagnosis of IBS-D according to the following symptoms-based criteria
as per 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:
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.

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.

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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 concurrent 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 concurrent
enrollment in a clinical study.

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

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Addresses

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    • Menarini Group
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    •   [---]*
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    • Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
    • Jan F Tack, Professor 
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    •   [---]*
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    • Angela Capriati, Dr. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.