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

NCT ID: NCT01303224

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ibodutant low dose

Oral tablet, to be given once daily in fasting conditions.

Group Type: EXPERIMENTAL

Ibodutant

Intervention Type: DRUG

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

Ibodutant intermediate dose

Oral tablet, to be given once daily in fasting conditions.

Group Type: EXPERIMENTAL

Ibodutant

Intervention Type: DRUG

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

Ibodutant high dose

Oral tablet, to be given once daily in fasting conditions.

Group Type: EXPERIMENTAL

Ibodutant

Intervention Type: DRUG

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

Placebo

Oral tablet, to be given once daily in fasting conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Ibodutant

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

Intervention Type: DRUG

Ibodutant

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

Intervention Type: DRUG

Ibodutant

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Code: MEN 15596; Code: MEN 15596; Code: MEN 15569; Sugar pill

Eligibility Criteria

Inclusion Criteria

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:

1. improvement with defecation;

2. onset associated with a change in the frequency of stool;

3. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, Professor

Role: STUDY_CHAIR

Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

Locations

MHAT "Haskovo", Second Internal Department

Haskovo, , Bulgaria

UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology

Pleven, , Bulgaria

MHAT "Kaspela", Department of Gastroenterology

Plovdiv, , Bulgaria

UMHAT "Sveti Georgi", Internal Consultative Department

Plovdiv, , Bulgaria

MHAT "Ruse", Clinic of Gastroenterology

Rousse, , Bulgaria

Fifth City Hospital, Gastroenterology Department

Sofia, , Bulgaria

UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease

Sofia, , Bulgaria

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

Sofia, , Bulgaria

UMHAT "St. Marina", Clinic of Gastroenterology

Varna, , Bulgaria

MHAT "Dr. Stefan Cherkezov", Gastroenterology Department

Veliko Tarnovo, , Bulgaria

Poliklinika III, Hepato-Gastroenterologie HK

Hradec Králové, , Czechia

Gastromedic s.r.o., Soukroma ordinace

Pardubice, , Czechia

IKEM, Klinika hepatogastroenterologie

Prague, , Czechia

Hospital Slany, Internal Department

Slaný, , Czechia

District Hospital, Internal Department

Strakonice, , Czechia

Regional Hospital Tabor, Gastroenterology

Tábor, , Czechia

Kojecký Soukroma Ordinace

Zlín, , Czechia

CCBR Aalborg

Aalborg, , Denmark

CCBR Ballerup

Ballerup Municipality, , Denmark

Gentofte Hospital, Medicinsk Afdeling F

Hellerup, , Denmark

Regionshospitalet Silkeborg, Medicinsk Afdeling F

Silkeborg, , Denmark

CCBR Vejle

Vejle, , Denmark

Klinische Forschung Berlin

Berlin, , Germany

Universitätsklinik Köln, Gastroenterologie

Cologne, , Germany

ABX-CRO Clinical Research GmbH

Dresden, , Germany

Private Practice Dr. Schaefer

Essen, , Germany

Clinical Research Hamburg

Hamburg, , Germany

Israelitisches Krankenhaus, Innere Medizin

Hamburg, , Germany

Gemeinschaftspraxis Kuchta, Wegner, Schiefke

Leipzig, , Germany

Praxis Prof. Kellner

Munich, , Germany

Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia

Como, , Italy

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

Ferrara, , Italy

Azienda Ospedaliero Universitaria Careggi, USOD Gastroenterologia 1

Florence, , Italy

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

Genoa, , Italy

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

Padua, , Italy

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

Pavia, , Italy

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

Pisa, , Italy

IRCCS Istituto Clinico Humanitas, Dipartimento di Gastroenterologia

Rozzano, , Italy

IRCCS Ospedale Casa Sollievo della Sofferenza, Divisione di Gastroenterologia

San Giovanni Rotondo, , Italy

NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"

Bialystok, , Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Gabinet Lekarski Janusz Rudziński

Bydgoszcz, , Poland

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

Grodzisk Mazowiecki, , Poland

Specjalistyczne Centrum Medyczne "NOWOMED"

Krakow, , Poland

5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Krakowie

Krakow, , Poland

NZOZ Krakowskie Centrum Medyczne

Krakow, , Poland

Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej

Lublin, , Poland

NZOZ "Centrum Alergologii"

Lublin, , Poland

NZOZ Solumed

Poznan, , Poland

NZOZ Zaspół Poradni Specjalistycznych "Artmed"

Poznan, , Poland

Endoskopia Sp. z o.o.

Sopot, , Poland

NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych

Torun, , Poland

NZOZ Remedis Sp z o.o.

Torun, , Poland

Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski

Warsaw, , Poland

Centrum Medyczne "Osteomed" Sp. z o. o

Warsaw, , Poland

Centralny Szpital Kliniczny MSWiA

Warsaw, , Poland

NZOZ Vivamed

Warsaw, , Poland

Hospital Germans Trias i Pujol, Digestive Unit

Badalona, , Spain

Centro Medico Teknon, Gastroenteloroly Service

Barcelona, , Spain

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

El Palmar (Murcia), , Spain

Hospital Clinico San Carlos, Digestive Diseases

Madrid, , Spain

Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives

Mataró, , Spain

Corporació Sanitària Parc Tauli

Sabadell, , Spain

Complejo Hospitalario Universitario de Santiago, Gastroenterology

Santiago de Compostela, , Spain

Hospital Virgen Macarena, Digestive Service

Seville, , Spain

Sahlgrenska Universitetssjukhuset, Mag-tarm lab

Gothenburg, , Sweden

Probare

Lund, , Sweden

Clinical Research Support, S-huset, Södra Grev Rosengatan

Örebro, , Sweden

Kärnsjukhuset

Skövde, , Sweden

Gastrocentrum Aleris specialistvård Sabbatsberg,

Stockholm, , Sweden

Akademiska sjukhuset, Gastromottagningen

Uppsala, , Sweden

Countries

Bulgaria; Czechia; Denmark; Germany; Italy; Poland; Spain; Sweden

References

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.

Reference Type: DERIVED

PMID: 27196574 (View on PubMed)

Other Identifiers

2010-018300-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NAK-04

Identifier Type: -

Identifier Source: org_study_id