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12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) (IRIS-3)

18 de noviembre de 2016 actualizado por: Menarini Group

A 12-Week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-Week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhea

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 oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment.

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.

Tipo de estudio

Intervencionista

Inscripción (Actual)

535

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10629
      • Berlin, Alemania, 13125
      • Essen, Alemania, 45355
      • Hamburg, Alemania, 22297
      • Hamburg, Alemania, 20253
    • Baden-Wuerttemberg
      • Stuttgart, Baden-Wuerttemberg, Alemania, 70593
  • Bulgaria
      • Haskovo, Bulgaria, 6300
      • Plovdiv, Bulgaria, 4002
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1407
      • Veliko Tarnovo, Bulgaria, 5000
  • España
      • Barcelona, España, 08035
      • Barcelona, España, 08022
      • Madrid, España, 28040
      • Sevilla, España, 41013
    • Barcelona
      • Badalona, Barcelona, España, 08916
      • Mataro, Barcelona, España, 8304
      • Sabadell, Barcelona, España, 08208
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35802
    • Arizona
      • Sherwood, Arizona, Estados Unidos, 72120
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
    • California
      • Artesia, California, Estados Unidos, 90701
      • Chula Vista, California, Estados Unidos, 91910
      • Encino, California, Estados Unidos, 91436
      • Mission Hills, California, Estados Unidos, 91345
      • Sacramento, California, Estados Unidos, 95821
      • San Diego, California, Estados Unidos, 92123
      • Upland, California, Estados Unidos, 91786
    • Colorado
      • Littleton, Colorado, Estados Unidos, 80127
    • Connecticut
      • Bristol, Connecticut, Estados Unidos, 06010
    • Florida
      • Boynton Beach, Florida, Estados Unidos, 33426
      • Brandon, Florida, Estados Unidos, 33511
      • Brooksville, Florida, Estados Unidos, 34601
      • Coral Gables, Florida, Estados Unidos, 33134
      • Gainesville, Florida, Estados Unidos, 32607
      • Hialeah, Florida, Estados Unidos, 33012
      • Jupiter, Florida, Estados Unidos, 33458
      • Miami, Florida, Estados Unidos, 33165
      • Miami, Florida, Estados Unidos, 33125
      • Miami, Florida, Estados Unidos, 33175
      • Miami, Florida, Estados Unidos, 33185
      • Miami Lakes, Florida, Estados Unidos, 33014
    • Illinois
      • Addison, Illinois, Estados Unidos, 60101
      • Chicago, Illinois, Estados Unidos, 60604
    • Kansas
      • Augusta, Kansas, Estados Unidos, 67010
      • Newton, Kansas, Estados Unidos, 67114
      • Wichita, Kansas, Estados Unidos, 67205
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
      • Madisonville, Kentucky, Estados Unidos, 42431
      • Owensboro, Kentucky, Estados Unidos, 42303
    • Louisiana
      • Crowley, Louisiana, Estados Unidos, 70526
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21215
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
      • Chesterfield, Michigan, Estados Unidos, 48047
      • Saginaw, Michigan, Estados Unidos, 48604
      • Troy, Michigan, Estados Unidos, 48098
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89128
    • New York
      • Hartsdale, New York, Estados Unidos, 10530
    • North Carolina
      • Fayetteville, North Carolina, Estados Unidos, 28304
      • Greensboro, North Carolina, Estados Unidos, 27408
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58103
    • Ohio
      • Akron, Ohio, Estados Unidos, 44302
      • Cincinnati, Ohio, Estados Unidos, 45242
      • Cincinnati, Ohio, Estados Unidos, 45219
      • Cleveland, Ohio, Estados Unidos, 44122
      • Columbus, Ohio, Estados Unidos, 43214
      • Dayton, Ohio, Estados Unidos, 45432
    • Pennsylvania
      • Reading, Pennsylvania, Estados Unidos, 19606
    • South Carolina
      • Greer, South Carolina, Estados Unidos, 29650
      • Simpsonville, South Carolina, Estados Unidos, 29681
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37421
      • Knoxville, Tennessee, Estados Unidos, 37912
      • Knoxville, Tennessee, Estados Unidos, 37919
      • Nashville, Tennessee, Estados Unidos, 37205
      • Smyrna, Tennessee, Estados Unidos, 37167
    • Texas
      • Beaumont, Texas, Estados Unidos, 77701
      • Houston, Texas, Estados Unidos, 77089
      • Houston, Texas, Estados Unidos, 77052
      • Hurst, Texas, Estados Unidos, 76054
      • San Antonio, Texas, Estados Unidos, 78229
      • Ste. Channelview, Texas, Estados Unidos, 77530
    • Utah
      • West Jordan, Utah, Estados Unidos, 84088
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26505
  • Federación Rusa
      • Kaluga, Federación Rusa, 248007
      • Moscow, Federación Rusa, 115446
      • Saint-Petersburg, Federación Rusa, 196247
      • Smolensk, Federación Rusa, 214019
      • St. Petersburg, Federación Rusa, 194295
      • St.Petersburg, Federación Rusa, 193015
      • Yaroslavl, Federación Rusa, 150000
  • Francia
      • Bordeaux, Francia, 33000
      • NICE Cedex, Francia, 06202
      • Nantes Cedex, Francia, 44093
      • Rouen, Francia, 76031
    • Ile-de-France
      • Bobigny, Ile-de-France, Francia, 93000
  • Italia
      • Bari, Italia, 70124
      • Bari, Italia, 70100
      • Bologna, Italia, 40138
      • Florence, Italia, 50139
      • Pavia, Italia, 27100
      • Rome, Italia, 00168
  • Polonia
      • Bydgoszcz, Polonia, 85-168
      • Czestochowa, Polonia, 42-200
      • Krakow, Polonia, 31009
      • Lublin, Polonia, 20-090
      • Wroclaw, Polonia, 53333
  • Reino Unido
      • Leicestershire, Reino Unido, LE10 2SE
      • Manchester, Reino Unido, M23 9LT
      • Plymouth, Devon, Reino Unido, PL5 3JB
    • Cornwall
      • Penzance, Cornwall, Reino Unido, TR18 4JH
    • Derbyshire
      • Chesterfield, Derbyshire, Reino Unido, S40 4AA
    • Scotland
      • Inverness, Scotland, Reino Unido, IV2 4AG
    • South Yorkshire
      • Doncaster, South Yorkshire, Reino Unido, DN2 5LT
  • República Checa
      • Karlovy Vary, República Checa, 360 66
      • Prague, República Checa, 14021
      • Prague, República Checa, 19000
      • Usti nad Labem, República Checa, 401 13
      • Usti nad Orlici, República Checa, 562 01
  • Rumania
      • Brasov, Rumania, 500326
      • Brasov, Rumania, 500283
      • Bucharest, Rumania, 50098
      • Bucharest, Rumania, 20125
    • Jud. Mures
      • Targu Mures, Jud. Mures, Rumania, 540461
    • Mures
      • Tirgu Mures, Mures, Rumania, 540098
    • Timis
      • Timisoara, Timis, Rumania, 300168
      • Timisoara, Timis, Rumania, 300193

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

At screening:

  • Female patients aged 18 years or older.

  • Clinical diagnosis of IBS-D according to the following symptoms-based criteria as per Rome III modular questionnaire criteria:

    1. Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
    2. Symptom-onset at least 6 months prior to diagnosis.
    3. Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
    4. Additional criterion: 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 a positive family history of colorectal cancer: normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years.
  • For patients aged 65 years or older: absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months.
  • For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period.
  • Physical examination without clinically relevant abnormalities during screening.
  • No clinically relevant abnormalities in 12-Lead ECG or in laboratory findings.
  • Mentally competent, able to give written informed consent, and compliant to undergo all visits and procedures.
  • Unrestricted access to a touch-tone telephone.
  • Willingness to refrain from using loperamide within 3 days prior to run-in visit and during the run-in period.

Additional criteria at randomisation:

  • During both weeks of the run-in period:

    1. A weekly average of worst abdominal pain in the past 24 hours with a score of ≥3.0 on a 0 to 10 point scale.
    2. At least one bowel movement on each day.
    3. A weekly average of at least 3 bowel movements per day.
    4. At least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week.
    5. Less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
  • Adequate compliance with the e-diary recording procedure defined as at least 11 of 14 days (≥75%) of the nominal daily data entry.

Exclusion Criteria:

  • Male gender.
  • Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.
  • Colonic or major abdominal surgery, any other major abdominal surgery or elective major surgery planned or expected during the study.
  • History of organic GI abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis.
  • History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months.
  • History of gluten enteropathy or lactose intolerance.
  • Current or previous diagnosis of neoplasia.
  • History of endometriosis.
  • History of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
  • History of human immunodeficiency virus infection.
  • History of major cardiovascular events in the previous 6 months.
  • Uncontrolled hypertension, insulin-dependent diabetes mellitus or abnormal thyroid function.
  • Major psychiatric or neurological disorders or unstable medical condition which may compromise the efficacy and safety assessments.
  • Evidence of clinically significant hepatic disease, severe renal insufficiency or anemia.
  • Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
  • Use of prohibited concurrent medication within the previous month such as antibiotics, antimuscarinic drugs, drugs enhancing GI motility and analgesics.
  • Pregnancy or breastfeeding.
  • Inability to understand or collaborate throughout the study.
  • Participation in other clinical studies in the previous 4 weeks or concurrent enrollment in a clinical study.
  • Any condition that would compromise the well-being of the patient.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Ibodutant 10 mg
Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.
Droga: Ibodutante 10 mg
Comprimido oral, para administrar una vez al día.
Otros nombres:
  • Código: HOMBRE 15596
Comparador de placebos: Placebo
Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.
Droga: Placebo
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
Otros nombres:
  • Pastilla de azucar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).
Periodo de tiempo: 12 weeks

The patient will be considered a weekly responder if she meets both of the following criteria in the same week:

  • Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
  • Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea.
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).
Periodo de tiempo: 12 weeks

The patient will be considered a weekly abdominal pain responder if she meets the following criterion:

  • Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.
12 weeks
Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).
Periodo de tiempo: 12 weeks

The patient will be considered a weekly stool consistency responder if she meets the following criterion:

  • Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea.
12 weeks
Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).
Periodo de tiempo: 12 weeks
The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to "completely relieved/improved" or "considerably relieved/improved".
12 weeks
Evaluation of Rebound Effects
Periodo de tiempo: 4 weeks

Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.

The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period.
4 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Menarini Group

Investigadores

  • Silla de estudio: Lin Chang, Professor, Digestive Health and Nutrition Clinic. University of California, Los Angeles, CA, USA
  • Silla de estudio: Jan F Tack, Professor, Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2014

Finalización primaria (Actual)

1 de junio de 2015

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

4 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

4 de abril de 2014

Publicado por primera vez (Estimar)

8 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

18 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NAK-06
  • 2013-000894-56 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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