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Irritable Bowel Syndrome With DiarrheaPhase 3IRIS-3NCT02107196

12-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 127 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
535 participants
Where
127 sitesin 11 countries
Study dates
Mar 2014to Jun 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.
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  • 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

127 sites in 11 countries.

127 sites in 11 countries

United States65 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Akron, Ohio, 44302

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Artesia, California, 90701

  • Study site

    Augusta, Kansas, 67010

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Beaumont, Texas, 77701

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Brandon, Florida, 33511

  • Study site

    Bristol, Connecticut, 06010

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Chattanooga, Tennessee, 37421

  • Study site

    Chesterfield, Michigan, 48047

  • Study site

    Chicago, Illinois, 60604

  • Study site

    Chula Vista, California, 91910

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Crowley, Louisiana, 70526

  • Study site

    Dayton, Ohio, 45432

  • Study site

    Encino, California, 91436

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Greer, South Carolina, 29650

  • Study site

    Hartsdale, New York, 10530

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77052

  • Study site

    Houston, Texas, 77089

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Hurst, Texas, 76054

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Knoxville, Tennessee, 37912

  • Study site

    Knoxville, Tennessee, 37919

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Littleton, Colorado, 80127

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Miami, Florida, 33125

  • Study site

    Miami, Florida, 33165

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami, Florida, 33185

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Mission Hills, California, 91345

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    Newton, Kansas, 67114

  • Study site

    Owensboro, Kentucky, 42303

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Sacramento, California, 95821

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92123

  • Study site

    Sherwood, Arizona, 72120

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Smyrna, Tennessee, 37167

  • Study site

    Ste. Channelview, Texas, 77530

  • Study site

    Troy, Michigan, 48098

  • Study site

    Upland, California, 91786

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wichita, Kansas, 67205

Other trials in United States

Romania8 sites

  • Study site

    Brasov, 500283

  • Study site

    Brasov, 500326

  • Study site

    Bucharest, 20125

  • Study site

    Bucharest, 50098

  • Study site

    Târgu Mureş, Jud. Mures, 540461

  • Study site

    Târgu Mureş, Mureș County, 540098

  • Study site

    Timișoara, Timiș County, 300168

  • Study site

    Timișoara, Timiș County, 300193

Other trials in Romania

Russia7 sites

  • Study site

    Kaluga, 248007

  • Study site

    Moscow, 115446

  • Study site

    Saint Petersburg, 193015

  • Study site

    Saint Petersburg, 194295

  • Study site

    Saint Petersburg, 196247

  • Study site

    Smolensk, 214019

  • Study site

    Yaroslavl, 150000

Other trials in Russia

Spain7 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08022

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28040

  • Study site

    Mataró, Barcelona, 8304

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Seville, 41013

Other trials in Spain

United Kingdom7 sites

  • Study site

    Chesterfield, Derbyshire, S40 4AA

  • Study site

    Doncaster, South Yorkshire, DN2 5LT

  • Study site

    Inverness, Scotland, IV2 4AG

  • Study site

    Leicestershire, LE10 2SE

  • Study site

    Manchester, M23 9LT

  • Study site

    Penzance, Cornwall, TR18 4JH

  • Study site

    Plymouth, Devon, PL5 3JB

Other trials in United Kingdom

Bulgaria6 sites

  • Study site

    Haskovo, 6300

  • Study site

    Plovdiv, 4002

  • Study site

    Rousse, 7002

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1431

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Germany6 sites

  • Study site

    Berlin, 10629

  • Study site

    Berlin, 13125

  • Study site

    Essen, 45355

  • Study site

    Hamburg, 20253

  • Study site

    Hamburg, 22297

  • Study site

    Stuttgart, Baden-Wurttemberg, 70593

Other trials in Germany

Italy6 sites

  • Study site

    Bari, 70100

  • Study site

    Bari, 70124

  • Study site

    Bologna, 40138

  • Study site

    Florence, 50139

  • Study site

    Pavia, 27100

  • Study site

    Rome, 00168

Other trials in Italy

Czechia5 sites

  • Study site

    Karlovy Vary, 360 66

  • Study site

    Prague, 14021

  • Study site

    Prague, 19000

  • Study site

    Ústí nad Labem, 401 13

  • Study site

    Ústí nad Orlicí, 562 01

Other trials in Czechia

France5 sites

  • Study site

    Bobigny, Île-de-France Region, 93000

  • Study site

    Bordeaux, 33000

  • Study site

    Nantes, 44093

  • Study site

    Nice, 06202

  • Study site

    Rouen, 76031

Other trials in France

Poland5 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Częstochowa, 42-200

  • Study site

    Krakow, 31009

  • Study site

    Lublin, 20-090

  • Study site

    Wroclaw, 53333

Other trials in Poland

About this study

Official 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 Diarrhea

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 12-week treatment period.

Read the detailed description

The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 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 12 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 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-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 NCT02107196
Study groupRoleWhat they receive
Ibodutant 10 mgExperimentalOral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Receives: Drug: Ibodutant 10 mg
PlaceboPlacebo comparatorOral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 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 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 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. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea.

    Measured: 12 weeks

Secondary outcomes (4)

  1. 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).

    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: 12 weeks

  2. Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).

    The patient will be considered a weekly stool consistency responder if 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. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea.

    Measured: 12 weeks

  3. 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).

    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".

    Measured: 12 weeks

  4. Evaluation of Rebound Effects

    Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.

    The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period.

    Measured: 4 weeks

Timeline

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

  1. First posted8 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107196
Sponsor's protocol ID
NAK-06
Other IDs
2013-000894-56
Acronym
IRIS-3
Status last verified
Nov 2016
First submitted
4 Apr 2014
Last updated
19 Jan 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 127 sites in 11 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: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Romania, Russia, Spain, United Kingdom and 6 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 27 Sep 2016). 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 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). (time frame: 12 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 NCT02107196.

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 19 Jan 2017.

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