Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
IRIS-2
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).
2 other identifiers
interventional
565
8 countries
71
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 23, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
March 25, 2013
CompletedOctober 7, 2015
September 1, 2015
1.6 years
February 23, 2011
January 10, 2013
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Eight weeks
Secondary Outcomes (2)
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
Eight weeks
Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)
Eight weeks
Other Outcomes (2)
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population
Eight weeks
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population
Eight weeks
Study Arms (4)
Ibodutant low dose
EXPERIMENTALOral tablet, to be given once daily in fasting conditions.
Ibodutant intermediate dose
EXPERIMENTALOral tablet, to be given once daily in fasting conditions.
Ibodutant high dose
EXPERIMENTALOral tablet, to be given once daily in fasting conditions.
Placebo
PLACEBO COMPARATOROral tablet, to be given once daily in fasting conditions.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Menarini Grouplead
Study Sites (71)
MHAT "Haskovo", Second Internal Department
Haskovo, 6300, Bulgaria
UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology
Pleven, 5800, Bulgaria
MHAT "Kaspela", Department of Gastroenterology
Plovdiv, 4000, Bulgaria
UMHAT "Sveti Georgi", Internal Consultative Department
Plovdiv, 4000, Bulgaria
MHAT "Ruse", Clinic of Gastroenterology
Rousse, 7002, Bulgaria
Fifth City Hospital, Gastroenterology Department
Sofia, 1233, Bulgaria
UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease
Sofia, 1431, Bulgaria
MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology
Sofia, 1784, Bulgaria
UMHAT "St. Marina", Clinic of Gastroenterology
Varna, 9010, Bulgaria
MHAT "Dr. Stefan Cherkezov", Gastroenterology Department
Veliko Tarnovo, 5000, Bulgaria
Poliklinika III, Hepato-Gastroenterologie HK
Hradec Králové, 500 12, Czechia
Gastromedic s.r.o., Soukroma ordinace
Pardubice, 530 02, Czechia
IKEM, Klinika hepatogastroenterologie
Prague, 140 21, Czechia
Hospital Slany, Internal Department
Slaný, 274 51, Czechia
District Hospital, Internal Department
Strakonice, 386 29, Czechia
Regional Hospital Tabor, Gastroenterology
Tábor, 390 03, Czechia
Kojecký Soukroma Ordinace
Zlín, 76005, Czechia
CCBR Aalborg
Aalborg, 9000, Denmark
CCBR Ballerup
Ballerup Municipality, 2750, Denmark
Gentofte Hospital, Medicinsk Afdeling F
Hellerup, 2900, Denmark
Regionshospitalet Silkeborg, Medicinsk Afdeling F
Silkeborg, 8600, Denmark
CCBR Vejle
Vejle, 7100, Denmark
Klinische Forschung Berlin
Berlin, 10787, Germany
Universitätsklinik Köln, Gastroenterologie
Cologne, 50937, Germany
ABX-CRO Clinical Research GmbH
Dresden, 01307, Germany
Private Practice Dr. Schaefer
Essen, 45355, Germany
Clinical Research Hamburg
Hamburg, 22143, Germany
Israelitisches Krankenhaus, Innere Medizin
Hamburg, 22297, Germany
Gemeinschaftspraxis Kuchta, Wegner, Schiefke
Leipzig, 04103, Germany
Praxis Prof. Kellner
Munich, 80639, Germany
Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia
Como, 22100, Italy
Azienda Ospedaliera Sant'Anna, U.O. Di Gastroenterologia
Ferrara, 44100, Italy
Azienda Ospedaliero Universitaria Careggi, USOD Gastroenterologia 1
Florence, 50134, Italy
Università degli Studi di Genova, Dipartimento di Medicina Interna e Specialità Mediche
Genoa, 16132, Italy
Azienda Ospedaliera - Università di Padova, Struttura Operativa Complessa di Gastroenterologia
Padua, 35128, Italy
IRCCS Policlinico San Matteo, Dipartimento di Medicina Interna I e Gastroenterologia
Pavia, 27100, Italy
"Ospedale Nuovo Santa Chiara-Cisanello, Dipartimento di Medicina Interna
Pisa, 56126, Italy
IRCCS Istituto Clinico Humanitas, Dipartimento di Gastroenterologia
Rozzano, 20089, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza, Divisione di Gastroenterologia
San Giovanni Rotondo, 71013, Italy
NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"
Bialystok, 15-531, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Gabinet Lekarski Janusz Rudziński
Bydgoszcz, 85-681, Poland
Mazowieckie Centrum Badań Klinicznych I.Czajkowska M.Śmietańska s.c.
Grodzisk Mazowiecki, 05-825, Poland
Specjalistyczne Centrum Medyczne "NOWOMED"
Krakow, 30-349, Poland
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Krakowie
Krakow, 30-901, Poland
NZOZ Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej
Lublin, 20-090, Poland
NZOZ "Centrum Alergologii"
Lublin, 20-637, Poland
NZOZ Solumed
Poznan, 60-539, Poland
NZOZ Zaspół Poradni Specjalistycznych "Artmed"
Poznan, 60-547, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych
Torun, 87-100, Poland
NZOZ Remedis Sp z o.o.
Torun, 87-100, Poland
Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski
Warsaw, 01-377, Poland
Centrum Medyczne "Osteomed" Sp. z o. o
Warsaw, 02-341, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507, Poland
NZOZ Vivamed
Warsaw, 03-580, Poland
Hospital Germans Trias i Pujol, Digestive Unit
Badalona, 08916, Spain
Centro Medico Teknon, Gastroenteloroly Service
Barcelona, 08022, Spain
"Hospital Universitario Virgen de la Arrixaca, Servicio de Medicina del Aparato Digestivo
El Palmar (Murcia), 30120, Spain
Hospital Clinico San Carlos, Digestive Diseases
Madrid, 28040, Spain
Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives
Mataró, 08304, Spain
Corporació Sanitària Parc Tauli
Sabadell, 08208, Spain
Complejo Hospitalario Universitario de Santiago, Gastroenterology
Santiago de Compostela, 15706, Spain
Hospital Virgen Macarena, Digestive Service
Seville, 41009, Spain
Sahlgrenska Universitetssjukhuset, Mag-tarm lab
Gothenburg, 413 45, Sweden
Probare
Lund, 223 61, Sweden
Clinical Research Support, S-huset, Södra Grev Rosengatan
Örebro, 703 62, Sweden
Kärnsjukhuset
Skövde, 541 85, Sweden
Gastrocentrum Aleris specialistvård Sabbatsberg,
Stockholm, 113 82, Sweden
Akademiska sjukhuset, Gastromottagningen
Uppsala, 751 85, Sweden
Related Publications (1)
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.
PMID: 27196574DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Capriati MD PhD, Corporate Director of Clinical Research
- Organization
- Menarini Ricerche S.p.A.
Study Officials
- STUDY CHAIR
Jan Tack, Professor
Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2011
First Posted
February 24, 2011
Study Start
October 1, 2010
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
October 7, 2015
Results First Posted
March 25, 2013
Record last verified: 2015-09