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Irritable Bowel Syndrome With DiarrheaPhase 2IRIS-2NCT01303224

Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

A Phase 2 study testing Ibodutant in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 71 sites in 8 countries.

Completed

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

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 the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Ibodutant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
565 participants
Where
71 sitesin 8 countries
Study dates
Oct 2010to Jul 2012
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At start of the run-in period:
  • Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria:
  • Recurrent abdominal pain/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.
Show all 15Show fewer
  • Symptom-onset at least 6 months prior to diagnosis.
  • Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months.
  • 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 or flexible sigmoidoscopy.
  • Mentally competent, able to give written informed consent.
  • For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment.
  • Normal physical examination or without clinically relevant abnormalities.
  • At randomisation:
  • -Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.

Who cannot join

  • Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery.
  • History of gluten enteropathy.
  • Lactose intolerance as assessed by response to diet.
  • History of positive tests for ova or parasites, or occult blood in the stool.
  • Previous diagnosis of diabetes mellitus (either type 1 or 2).
  • Unstable medical condition.
Show all 10Show fewer
  • Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
  • Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
  • Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity.
  • Pregnancy or breastfeeding.

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

Poland18 sites

  • NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"

    Bialystok, 15-531

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Gabinet Lekarski Janusz Rudziński

    Bydgoszcz, 85-681

  • Mazowieckie Centrum Badań Klinicznych I.Czajkowska M.Śmietańska s.c.

    Grodzisk Mazowiecki, 05-825

  • Specjalistyczne Centrum Medyczne "NOWOMED"

    Krakow, 30-349

  • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Krakowie

    Krakow, 30-901

  • NZOZ Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej

    Lublin, 20-090

  • NZOZ "Centrum Alergologii"

    Lublin, 20-637

  • NZOZ Solumed

    Poznan, 60-539

  • NZOZ Zaspół Poradni Specjalistycznych "Artmed"

    Poznan, 60-547

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych

    Torun, 87-100

  • NZOZ Remedis Sp z o.o.

    Torun, 87-100

  • Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski

    Warsaw, 01-377

  • Centrum Medyczne "Osteomed" Sp. z o. o

    Warsaw, 02-341

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-507

  • NZOZ Vivamed

    Warsaw, 03-580

Other trials in Poland

Bulgaria10 sites

  • MHAT "Haskovo", Second Internal Department

    Haskovo, 6300

  • UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology

    Pleven, 5800

  • MHAT "Kaspela", Department of Gastroenterology

    Plovdiv, 4000

  • UMHAT "Sveti Georgi", Internal Consultative Department

    Plovdiv, 4000

  • MHAT "Ruse", Clinic of Gastroenterology

    Rousse, 7002

  • Fifth City Hospital, Gastroenterology Department

    Sofia, 1233

  • UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease

    Sofia, 1431

  • MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology

    Sofia, 1784

  • UMHAT "St. Marina", Clinic of Gastroenterology

    Varna, 9010

  • MHAT "Dr. Stefan Cherkezov", Gastroenterology Department

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Italy9 sites

  • Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia

    Como, 22100

  • Azienda Ospedaliera Sant'Anna, U.O. Di Gastroenterologia

    Ferrara, 44100

  • Azienda Ospedaliero Universitaria Careggi, USOD Gastroenterologia 1

    Florence, 50134

  • Università degli Studi di Genova, Dipartimento di Medicina Interna e Specialità Mediche

    Genoa, 16132

  • Azienda Ospedaliera - Università di Padova, Struttura Operativa Complessa di Gastroenterologia

    Padua, 35128

  • IRCCS Policlinico San Matteo, Dipartimento di Medicina Interna I e Gastroenterologia

    Pavia, 27100

  • "Ospedale Nuovo Santa Chiara-Cisanello, Dipartimento di Medicina Interna

    Pisa, 56126

  • IRCCS Istituto Clinico Humanitas, Dipartimento di Gastroenterologia

    Rozzano, 20089

  • IRCCS Ospedale Casa Sollievo della Sofferenza, Divisione di Gastroenterologia

    San Giovanni Rotondo, 71013

Other trials in Italy

Germany8 sites

  • Klinische Forschung Berlin

    Berlin, 10787

  • Universitätsklinik Köln, Gastroenterologie

    Cologne, 50937

  • ABX-CRO Clinical Research GmbH

    Dresden, 01307

  • Private Practice Dr. Schaefer

    Essen, 45355

  • Clinical Research Hamburg

    Hamburg, 22143

  • Israelitisches Krankenhaus, Innere Medizin

    Hamburg, 22297

  • Gemeinschaftspraxis Kuchta, Wegner, Schiefke

    Leipzig, 04103

  • Praxis Prof. Kellner

    Munich, 80639

Other trials in Germany

Spain8 sites

  • Hospital Germans Trias i Pujol, Digestive Unit

    Badalona, 08916

  • Centro Medico Teknon, Gastroenteloroly Service

    Barcelona, 08022

  • "Hospital Universitario Virgen de la Arrixaca, Servicio de Medicina del Aparato Digestivo

    El Palmar (Murcia), 30120

  • Hospital Clinico San Carlos, Digestive Diseases

    Madrid, 28040

  • Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives

    Mataró, 08304

  • Corporació Sanitària Parc Tauli

    Sabadell, 08208

  • Complejo Hospitalario Universitario de Santiago, Gastroenterology

    Santiago de Compostela, 15706

  • Hospital Virgen Macarena, Digestive Service

    Seville, 41009

Other trials in Spain

Czechia7 sites

  • Poliklinika III, Hepato-Gastroenterologie HK

    Hradec Králové, 500 12

  • Gastromedic s.r.o., Soukroma ordinace

    Pardubice, 530 02

  • IKEM, Klinika hepatogastroenterologie

    Prague, 140 21

  • Hospital Slany, Internal Department

    Slaný, 274 51

  • District Hospital, Internal Department

    Strakonice, 386 29

  • Regional Hospital Tabor, Gastroenterology

    Tábor, 390 03

  • Kojecký Soukroma Ordinace

    Zlín, 76005

Other trials in Czechia

Sweden6 sites

  • Sahlgrenska Universitetssjukhuset, Mag-tarm lab

    Gothenburg, 413 45

  • Probare

    Lund, 223 61

  • Clinical Research Support, S-huset, Södra Grev Rosengatan

    Örebro, 703 62

  • Kärnsjukhuset

    Skövde, 541 85

  • Gastrocentrum Aleris specialistvård Sabbatsberg,

    Stockholm, 113 82

  • Akademiska sjukhuset, Gastromottagningen

    Uppsala, 751 85

Other trials in Sweden

Denmark5 sites

  • CCBR Aalborg

    Aalborg, 9000

  • CCBR Ballerup

    Ballerup Municipality, 2750

  • Gentofte Hospital, Medicinsk Afdeling F

    Hellerup, 2900

  • Regionshospitalet Silkeborg, Medicinsk Afdeling F

    Silkeborg, 8600

  • CCBR Vejle

    Vejle, 7100

Other trials in Denmark

About this study

Official title: Double-blind, Randomised, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Effect of Oral Ibodutant in 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 the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

Read the detailed description

The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.

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

What participants receive

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

  • IbodutantDrug

    Also called Code: MEN 15596

    Oral tablet, low dose, once daily, for 8 weeks

  • IbodutantDrug

    Also called Code: MEN 15596

    Oral tablet, intermediate dose, once daily, for 8 weeks

  • IbodutantDrug

    Also called Code: MEN 15569

    Oral tablet, high dose, once daily, for 8 weeks

  • PlaceboDrug

    Also called Sugar pill

    Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks

Study groups in NCT01303224
Study groupRoleWhat they receive
Ibodutant low doseExperimentalOral tablet, to be given once daily in fasting conditions.
Receives: Drug: Ibodutant
Ibodutant intermediate doseExperimentalOral tablet, to be given once daily in fasting conditions.
Receives: Drug: Ibodutant
Ibodutant high doseExperimentalOral tablet, to be given once daily in fasting conditions.
Receives: Drug: Ibodutant
PlaceboPlacebo comparatorOral tablet, to be given once daily in fasting conditions.
Receives: Drug: Placebo

What is being measured

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

  1. Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).

    Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?"

    Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule)

    Measured: Eight weeks

Secondary outcomes (2)

  1. Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population

    Weekly binary questions (yes/no) from IV/WRS diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?"

    Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)

    Measured: Eight weeks

  2. Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)

    Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from "0"= worst imaginable health state to "100"=best imaginable health state.

    Measured: Eight weeks

Timeline

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

  1. First posted24 Feb 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2012
  4. Study completionJul 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303224
Sponsor's protocol ID
NAK-04
Other IDs
2010-018300-85
Acronym
IRIS-2
Status last verified
Sep 2015
First submitted
23 Feb 2011
Last updated
7 Oct 2015
Data monitoring committee
No

Publications

  • Tack J, Schumacher K, Tonini G, Scartoni S, Capriati A, Maggi CA; Iris-2 investigators. The neurokinin-2 receptor antagonist ibodutant improves overall symptoms, abdominal pain and stool pattern in female patients in a phase II study of diarrhoea-predominant IBS. Gut. 2017 Aug;66(8):1403-1413. doi: 10.1136/gutjnl-2015-310683. Epub 2016 Apr 15.

    PubMed 27196574

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibodutant in people with Irritable Bowel Syndrome With Diarrhea, run by Menarini Group at 71 sites in 8 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 15 inclusion and 10 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Poland, Bulgaria, Italy, Germany, Spain and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Mar 2013). 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?

Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). (time frame: Eight 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 NCT01303224, which also lists 1 linked publication.

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 7 Oct 2015.

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