Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- Drug: Placebo
- Registration Number
- NCT01303224
- Lead Sponsor
- Menarini Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 565
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral tablet, to be given once daily in fasting conditions. Ibodutant low dose Ibodutant Oral tablet, to be given once daily in fasting conditions. Ibodutant intermediate dose Ibodutant Oral tablet, to be given once daily in fasting conditions. Ibodutant high dose Ibodutant Oral tablet, to be given once daily in fasting conditions.
- Primary Outcome Measures
Name Time Method 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). Eight weeks 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
Name Time Method 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 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) Eight weeks 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.
Trial Locations
- Locations (71)
MHAT "Haskovo", Second Internal Department
🇧🇬Haskovo, Bulgaria
Fifth City Hospital, Gastroenterology Department
🇧🇬Sofia, Bulgaria
Kojecký Soukroma Ordinace
🇨🇿Zlin, Czech Republic
NZOZ "Centrum Alergologii"
🇵🇱Lublin, Poland
District Hospital, Internal Department
🇨🇿Strakonice, Czech Republic
Regional Hospital Tabor, Gastroenterology
🇨🇿Tabor, Czech Republic
NZOZ Specjalistyczne Centrum Gastrologii "Gastromed"
🇵🇱Białystok, Poland
Gabinet Lekarski Janusz Rudziński
🇵🇱Bydgoszcz, Poland
UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology
🇧🇬Pleven, Bulgaria
UMHAT "Sveti Georgi", Internal Consultative Department
🇧🇬Plovdiv, Bulgaria
MHAT "Ruse", Clinic of Gastroenterology
🇧🇬Ruse, Bulgaria
UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease
🇧🇬Sofia, Bulgaria
MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology
🇧🇬Sofia, Bulgaria
MHAT "Dr. Stefan Cherkezov", Gastroenterology Department
🇧🇬Veliko Tarnovo, Bulgaria
UMHAT "St. Marina", Clinic of Gastroenterology
🇧🇬Varna, Bulgaria
Poliklinika III, Hepato-Gastroenterologie HK
🇨🇿Hradec Kralove, Czech Republic
Gastromedic s.r.o., Soukroma ordinace
🇨🇿Pardubice, Czech Republic
Hospital Slany, Internal Department
🇨🇿Slany, Czech Republic
IKEM, Klinika hepatogastroenterologie
🇨🇿Prague, Czech Republic
Gentofte Hospital, Medicinsk Afdeling F
🇩🇰Hellerup, Denmark
CCBR Vejle
🇩🇰Vejle, Denmark
Klinische Forschung Berlin
🇩🇪Berlin, Germany
ABX-CRO Clinical Research GmbH
🇩🇪Dresden, Germany
Universitätsklinik Köln, Gastroenterologie
🇩🇪Cologne, Germany
Private Practice Dr. Schaefer
🇩🇪Essen, Germany
Ospedale Valduce, Unità Operativa Complessa di Gastroenterologia
🇮🇹Como, Italy
Clinical Research Hamburg
🇩🇪Hamburg, Germany
Israelitisches Krankenhaus, Innere Medizin
🇩🇪Hamburg, Germany
Gemeinschaftspraxis Kuchta, Wegner, Schiefke
🇩🇪Leipzig, Germany
Praxis Prof. Kellner
🇩🇪Munich, Germany
NZOZ Krakowskie Centrum Medyczne
🇵🇱Krakov, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Mazowieckie Centrum Badań Klinicznych I.Czajkowska M.Śmietańska s.c.
🇵🇱Grodzisk Mazowiecki, Poland
Specjalistyczne Centrum Medyczne "NOWOMED"
🇵🇱Krakov, Poland
5 Wojskowy Szpital Kliniczny z PoliklinikÄ… SPZOZ w Krakowie
🇵🇱Krakov, Poland
Instytut Medycyny Wsi im. Witolda Chodźki Publiczny Zakład Opieki Zdrowotnej
🇵🇱Lublin, Poland
NZOZ Solumed
🇵🇱Poznań, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych
🇵🇱Toruń, Poland
NZOZ Zaspół Poradni Specjalistycznych "Artmed"
🇵🇱Poznań, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Centrum Medyczne "Osteomed" Sp. z o. o
🇵🇱Warsaw, Poland
NZOZ Remedis Sp z o.o.
🇵🇱Toruń, Poland
Centrum Badawcze Współczesnej Terapii, Prywatny Gabinet Lekarski
🇵🇱Warsaw, Poland
Centralny Szpital Kliniczny MSWiA
🇵🇱Warsaw, Poland
NZOZ Vivamed
🇵🇱Warsaw, Poland
Centro Medico Teknon, Gastroenteloroly Service
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol, Digestive Unit
🇪🇸Badalona, 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
Sahlgrenska Universitetssjukhuset, Mag-tarm lab
🇸🇪Gothenburg, Sweden
Hospital de Mataró, Unitat d'Exploracions Funcionals Digestives
🇪🇸Mataró, Spain
Complejo Hospitalario Universitario de Santiago, Gastroenterology
🇪🇸Santiago de Compostela, Spain
Corporació Sanità ria Parc Tauli
🇪🇸Sabadell, Spain
Hospital Virgen Macarena, Digestive Service
🇪🇸Sevilla, Spain
Probare
🇸🇪Lund, Sweden
Kärnsjukhuset
🇸🇪Skövde, Sweden
Gastrocentrum Aleris specialistvård Sabbatsberg,
🇸🇪Stockholm, Sweden
CCBR Aalborg
🇩🇰Aalborg, Denmark
CCBR Ballerup
🇩🇰Ballerup, Denmark
Regionshospitalet Silkeborg, Medicinsk Afdeling F
🇩🇰Silkeborg, Denmark
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
MHAT "Kaspela", Department of Gastroenterology
🇧🇬Plovdiv, Bulgaria
Clinical Research Support, S-huset, Södra Grev Rosengatan
🇸🇪Örebro, Sweden
Akademiska sjukhuset, Gastromottagningen
🇸🇪Uppsala, Sweden