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Irritable Bowel Syndrome With DiarrheaPhase 3IRIS-4NCT02120027

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

A Phase 3 study testing Ibodutant 10 mg in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 139 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Ibodutant 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
139 sitesin 9 countries
Study dates
Feb 2014to Nov 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 23Show fewer
  • 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:
  • 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.
  • At least one bowel movement on each day.
  • A weekly average of at least 3 bowel movements per day.
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

139 sites in 9 countries.

139 sites in 9 countries

United States73 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Arlington, Texas, 76012

  • Study site

    Billings, Montana, 59102

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brockton, Massachusetts, 02302

  • Study site

    Brooklyn, New York, 11235

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Clive, Iowa, 50325

  • Study site

    Colorado Springs, Colorado, 80906

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Encino, California, 91436

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Gold River, California, 95670

  • Study site

    Great Neck, New York, 11023

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Houston, Texas, 77074

  • Study site

    Inverness, Florida, 34452

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Kinston, North Carolina, 28501-1584

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Levittown, Pennsylvania, 19056

  • Study site

    Lincoln, California, 95648

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Little Rock, Arkansas, 72212

  • Study site

    Logan, Utah, 84341

  • Study site

    Lynchburgh, Virginia, 24502

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Mesa, Arizona, 85202

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33165

  • Study site

    Miami, Florida, 33173

  • Study site

    Miami, Florida, 33185

  • Study site

    Miami, Florida, 33186

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Miami Lakes, Florida, 33016

  • Study site

    New York, New York, 10016

  • Study site

    Newington, New Hampshire, 03801

  • Study site

    North Hollywood, California, 91606

  • Study site

    North Little Rock, Arkansas, 72117

  • Study site

    Oak Lawn, Illinois, 60453

  • Study site

    Ogden, Utah, 84405

  • Study site

    Orange, California, 92868

  • Study site

    Pasadena, California, 91105

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Pinellas Park, Florida, 33782

  • Study site

    Rockford, Illinois, 61107

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92108

  • Study site

    Sandy City, Utah, 84094

  • Study site

    Seattle, Washington, 98105

  • Study site

    Shawnee, Kansas, 66218

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Spokane, Washington, 99208

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Tamarac, Florida, 33319

  • Study site

    Tampa, Florida, 33606

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyoming, Michigan, 49519

Other trials in United States

Poland12 sites

  • Study site

    Katowice, 40772

  • Study site

    Lodz, 90153

  • Study site

    Poznan, 60355

  • Study site

    Poznan, 61606

  • Study site

    Sopot, 81756

  • Study site

    Staszów, 28100

  • Study site

    Warsaw, 01231

  • Study site

    Warsaw, 02018

  • Study site

    Warsaw, 02679

  • Study site

    Warsaw, 03580

  • Study site

    Wroclaw, 50556

  • Study site

    Wroclaw, 54144

Other trials in Poland

United Kingdom11 sites

  • Study site

    Bexhill-on-Sea, TN40 1JJ

  • Study site

    Chorley, PR7 7NA

  • Study site

    Coventry, CV2 2DX

  • Study site

    Edgbaston, B15 2SQ

  • Study site

    Glasgow, G20 0SP

  • Study site

    Llanishen, CF14 5GJ

  • Study site

    North Manchester, M15 6SX

  • Study site

    Northumberland, NE46 1QJ

  • Study site

    Norwich, NR4 7UY

  • Study site

    Reading, RG2 0TG

  • Study site

    Waterloo, L22 0LG

Other trials in United Kingdom

Germany10 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 12627

  • Study site

    Bochum, 44787

  • Study site

    Frankfurt, 60596

  • Study site

    Hamburg, 22297

  • Study site

    Hanover, 30159

  • Study site

    Karlsruhe, 76199

  • Study site

    Leipzig, 04103

  • Study site

    Mainz, 55116

  • Study site

    Schwerin, 19055

Other trials in Germany

Hungary10 sites

  • Study site

    Budapest, 1088

  • Study site

    Budapest, 1136

  • Study site

    Budapest, H 1032

  • Study site

    Debrecen, 4032

  • Study site

    Debrecen, 4043

  • Study site

    Gyula, 5703

  • Study site

    Mátészalka, 4700

  • Study site

    Pécs, 7624

  • Study site

    Szekszárd, 7100

  • Study site

    Vác, 2600

Other trials in Hungary

Czechia7 sites

  • Study site

    České Budějovice, 37001

  • Study site

    Hradec Králové, 500 02

  • Study site

    Kralove, 50012

  • Study site

    Prague, 130 00

  • Study site

    Příbram, 26126

  • Study site

    Slaný, 274 51

  • Study site

    Zlín, 76001

Other trials in Czechia

Slovakia7 sites

  • Study site

    Bratislava, 82107

  • Study site

    Bratislava, 83104

  • Study site

    Bratislava, 85101

  • Study site

    Ilava, 01901

  • Study site

    Nitra, 94901

  • Study site

    Trenčín, 91101

  • Study site

    Trnava, 91701

Other trials in Slovakia

Latvia5 sites

  • Study site

    Daugavpils, 5417

  • Study site

    Riga, 1002

  • Study site

    Riga, 1005

  • Study site

    Riga III, 1006

  • Study site

    Valmiera, 4201

Other trials in Latvia

Sweden4 sites

  • Study site

    Gothenburg, 41345

  • Study site

    Lund, 22222

  • Study site

    Stockholm, 14186

  • Study site

    Uppsala, 75185

Other trials in Sweden

About this study

Official 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)

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.

Read the detailed description

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 28-week re-randomised double-blind treatment 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.

Being tested
Ibodutant 10 mg, Placebo
Keywords
Irritable Bowel Syndrome, Colon, irritable, Bowel disease, Diarrhea
Medical subject headings
Irritable Bowel Syndrome, Intestinal Diseases, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibodutant 10 mgDrug

    Also called Code: MEN 15596

    Oral tablet, to be given once daily.

  • PlaceboDrug

    Also called Sugar pill

    Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily.

Study groups in NCT02120027
Study groupRoleWhat they receive
Ibodutant 10 mgExperimentalOral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .
Receives: Drug: Ibodutant 10 mg
PlaceboPlacebo comparatorOral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    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 (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain);
    • 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 (patients reported their stool consistency response using the Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea).

    Measured: 24 weeks

Secondary outcomes (4)

  1. 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).

    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.

    Measured: 24 weeks

  2. 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).

    The patient was considered a weekly stool consistency responder if she met 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.

    Measured: 24 weeks

  3. 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)

    The patient was considered a weekly responder if she has an IBS degree-of-relief equal to "completely relieved/improved" or "considerably relieved/improved".

    Weekly e-diary assessment of IBS degree-of-relief of overall on signs or symptoms over the last 7 days was collected using a balanced 7-point Likert scale with 1= Completely relieved/improved, 2= Considerably relieved/improved, 3=Somewhat relieved/improved, 4= Unchanged, 5= Somewhat worse, 6=Considerably worse, 7= As bad as I can imagine.

    Measured: 24 weeks

  4. Sustained Analysis of Response for Abdominal Pain AND Stool Consistency Over First 24-week Double-blind Treatment Period

    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) 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Why it stopped: Because of negative results of the sister study NAK-06 and the low overall response rate at week 24.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120027
Sponsor's protocol ID
NAK-07
Other IDs
2013-000895-14
Acronym
IRIS-4
Status last verified
Jan 2017
First submitted
17 Apr 2014
Last updated
3 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibodutant 10 mg in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 139 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Poland, United Kingdom, Germany, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02120027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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