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Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D) (IRIS-2)

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ibodutant
Ibodutant
Ibodutant
Placebo
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring Irritable Bowel Syndrome, Colon, irritable, Bowel disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MHAT "Haskovo", Second Internal Department
  • UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology
  • MHAT "Kaspela", Department of Gastroenterology
  • UMHAT "Sveti Georgi", Internal Consultative Department
  • MHAT "Ruse", Clinic of Gastroenterology
  • Fifth City Hospital, Gastroenterology Department
  • UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease
  • MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology
  • UMHAT "St. Marina", Clinic of Gastroenterology
  • MHAT "Dr. Stefan Cherkezov", Gastroenterology Department
  • Poliklinika III, Hepato-Gastroenterologie HK
  • Gastromedic s.r.o., Soukroma ordinace
  • IKEM, Klinika hepatogastroenterologie
  • Hospital Slany, Internal Department
  • District Hospital, Internal Department
  • Regional Hospital Tabor, Gastroenterology
  • Kojecký Soukroma Ordinace
  • CCBR Aalborg
  • CCBR Ballerup
  • Gentofte Hospital, Medicinsk Afdeling F
  • Regionshospitalet Silkeborg, Medicinsk Afdeling F
  • CCBR Vejle
  • Klinische Forschung Berlin
  • Universitätsklinik Köln, Gastroenterologie
  • ABX-CRO Clinical Research GmbH
  • Private Practice Dr. Schaefer
  • Clinical Research Hamburg
  • Israelitisches Krankenhaus, Innere Medizin
  • Gemeinschaftspraxis Kuchta, Wegner, Schiefke
  • Praxis Prof. Kellner
  • Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia
  • Azienda Ospedaliera Sant'Anna, U.O. Di Gastroenterologia
  • Azienda Ospedaliero Universitaria Careggi, USOD Gastroenterologia 1
  • Università degli Studi di Genova, Dipartimento di Medicina Interna e Specialità Mediche
  • Azienda Ospedaliera - Università di Padova, Struttura Operativa Complessa di Gastroenterologia
  • IRCCS Policlinico San Matteo, Dipartimento di Medicina Interna I e Gastroenterologia
  • "Ospedale Nuovo Santa Chiara-Cisanello, Dipartimento di Medicina Interna
  • IRCCS Istituto Clinico Humanitas, Dipartimento di Gastroenterologia
  • IRCCS Ospedale Casa Sollievo della Sofferenza, Divisione di Gastroenterologia
  • NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"
  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
  • Gabinet Lekarski Janusz Rudziński
  • Mazowieckie Centrum Badań Klinicznych I.Czajkowska M.Śmietańska s.c.
  • Specjalistyczne Centrum Medyczne "NOWOMED"
  • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Krakowie
  • NZOZ Krakowskie Centrum Medyczne
  • Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej
  • NZOZ "Centrum Alergologii"
  • NZOZ Solumed
  • NZOZ Zaspół Poradni Specjalistycznych "Artmed"
  • Endoskopia Sp. z o.o.
  • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych
  • NZOZ Remedis Sp z o.o.
  • Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski
  • Centrum Medyczne "Osteomed" Sp. z o. o
  • Centralny Szpital Kliniczny MSWiA
  • NZOZ Vivamed
  • Hospital Germans Trias i Pujol, Digestive Unit
  • Centro Medico Teknon, Gastroenteloroly Service
  • "Hospital Universitario Virgen de la Arrixaca, Servicio de Medicina del Aparato Digestivo
  • Hospital Clinico San Carlos, Digestive Diseases
  • Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives
  • Corporació Sanitària Parc Tauli
  • Complejo Hospitalario Universitario de Santiago, Gastroenterology
  • Hospital Virgen Macarena, Digestive Service
  • Sahlgrenska Universitetssjukhuset, Mag-tarm lab
  • Probare
  • Kärnsjukhuset
  • Gastrocentrum Aleris specialistvård Sabbatsberg,
  • Akademiska sjukhuset, Gastromottagningen
  • Clinical Research Support, S-huset, Södra Grev Rosengatan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Ibodutant low dose

Ibodutant intermediate dose

Ibodutant high dose

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.

Full Information

First Posted
February 23, 2011
Last Updated
September 22, 2015
Sponsor
Menarini Group
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1. Study Identification

Unique Protocol Identification Number
NCT01303224
Brief Title
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Acronym
IRIS-2
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
Irritable Bowel Syndrome, Colon, irritable, Bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
565 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibodutant low dose
Arm Type
Experimental
Arm Description
Oral tablet, to be given once daily in fasting conditions.
Arm Title
Ibodutant intermediate dose
Arm Type
Experimental
Arm Description
Oral tablet, to be given once daily in fasting conditions.
Arm Title
Ibodutant high dose
Arm Type
Experimental
Arm Description
Oral tablet, to be given once daily in fasting conditions.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral tablet, to be given once daily in fasting conditions.
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15596
Intervention Description
Oral tablet, low dose, once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15596
Intervention Description
Oral tablet, intermediate dose, once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15569
Intervention Description
Oral tablet, high dose, once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Primary Outcome Measure Information:
Title
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).
Description
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)
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
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
Description
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)
Time Frame
Eight weeks
Title
Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)
Description
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.
Time Frame
Eight weeks
Other Pre-specified Outcome Measures:
Title
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population
Description
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" 6/8 weeks (75% rule)
Time Frame
Eight weeks
Title
Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population
Description
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" 6/8 weeks (75% rule)
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Professor
Organizational Affiliation
Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
MHAT "Haskovo", Second Internal Department
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT "Kaspela", Department of Gastroenterology
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT "Sveti Georgi", Internal Consultative Department
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT "Ruse", Clinic of Gastroenterology
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Fifth City Hospital, Gastroenterology Department
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
UMHAT "St. Marina", Clinic of Gastroenterology
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
MHAT "Dr. Stefan Cherkezov", Gastroenterology Department
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Poliklinika III, Hepato-Gastroenterologie HK
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Gastromedic s.r.o., Soukroma ordinace
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
IKEM, Klinika hepatogastroenterologie
City
Prague
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Hospital Slany, Internal Department
City
Slany
ZIP/Postal Code
274 51
Country
Czech Republic
Facility Name
District Hospital, Internal Department
City
Strakonice
ZIP/Postal Code
386 29
Country
Czech Republic
Facility Name
Regional Hospital Tabor, Gastroenterology
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Kojecký Soukroma Ordinace
City
Zlin
ZIP/Postal Code
76005
Country
Czech Republic
Facility Name
CCBR Aalborg
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
CCBR Ballerup
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Gentofte Hospital, Medicinsk Afdeling F
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Regionshospitalet Silkeborg, Medicinsk Afdeling F
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
CCBR Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Klinische Forschung Berlin
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Universitätsklinik Köln, Gastroenterologie
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
ABX-CRO Clinical Research GmbH
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Private Practice Dr. Schaefer
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Clinical Research Hamburg
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Israelitisches Krankenhaus, Innere Medizin
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Gemeinschaftspraxis Kuchta, Wegner, Schiefke
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Praxis Prof. Kellner
City
Munich
ZIP/Postal Code
80639
Country
Germany
Facility Name
Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Anna, U.O. Di Gastroenterologia
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi, USOD Gastroenterologia 1
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Università degli Studi di Genova, Dipartimento di Medicina Interna e Specialità Mediche
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera - Università di Padova, Struttura Operativa Complessa di Gastroenterologia
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Policlinico San Matteo, Dipartimento di Medicina Interna I e Gastroenterologia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
"Ospedale Nuovo Santa Chiara-Cisanello, Dipartimento di Medicina Interna
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas, Dipartimento di Gastroenterologia
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza, Divisione di Gastroenterologia
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"
City
Białystok
ZIP/Postal Code
15-531
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Gabinet Lekarski Janusz Rudziński
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Mazowieckie Centrum Badań Klinicznych I.Czajkowska M.Śmietańska s.c.
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Specjalistyczne Centrum Medyczne "NOWOMED"
City
Krakov
ZIP/Postal Code
30-349
Country
Poland
Facility Name
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Krakowie
City
Krakov
ZIP/Postal Code
30-901
Country
Poland
Facility Name
NZOZ Krakowskie Centrum Medyczne
City
Krakov
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
NZOZ "Centrum Alergologii"
City
Lublin
ZIP/Postal Code
20-637
Country
Poland
Facility Name
NZOZ Solumed
City
Poznań
ZIP/Postal Code
60-539
Country
Poland
Facility Name
NZOZ Zaspół Poradni Specjalistycznych "Artmed"
City
Poznań
ZIP/Postal Code
60-547
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
NZOZ Remedis Sp z o.o.
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski
City
Warsaw
ZIP/Postal Code
01-377
Country
Poland
Facility Name
Centrum Medyczne "Osteomed" Sp. z o. o
City
Warsaw
ZIP/Postal Code
02-341
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
NZOZ Vivamed
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Hospital Germans Trias i Pujol, Digestive Unit
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Centro Medico Teknon, Gastroenteloroly Service
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
"Hospital Universitario Virgen de la Arrixaca, Servicio de Medicina del Aparato Digestivo
City
El Palmar (Murcia)
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Clinico San Carlos, Digestive Diseases
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives
City
Mataró
ZIP/Postal Code
08304
Country
Spain
Facility Name
Corporació Sanitària Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago, Gastroenterology
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Virgen Macarena, Digestive Service
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset, Mag-tarm lab
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Probare
City
Lund
ZIP/Postal Code
223 61
Country
Sweden
Facility Name
Kärnsjukhuset
City
Skövde
ZIP/Postal Code
541 85
Country
Sweden
Facility Name
Gastrocentrum Aleris specialistvård Sabbatsberg,
City
Stockholm
ZIP/Postal Code
113 82
Country
Sweden
Facility Name
Akademiska sjukhuset, Gastromottagningen
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Clinical Research Support, S-huset, Södra Grev Rosengatan
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27196574
Citation
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.
Results Reference
derived

Learn more about this trial

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

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