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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 novembre 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

535

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Ibodutant 10 mg
Comprimé oral, à administrer une fois par jour.
Autres noms:
  • Code : HOMME 15596
Comparateur placebo: 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.
Médicament: Placebo
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
Autres noms:
  • Pilule de sucre

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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).
Délai: 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).
Délai: 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).
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Menarini Group

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2014

Achèvement primaire (Réel)

1 juin 2015

Achèvement de l'étude (Réel)

1 juin 2015

Dates d'inscription aux études

Première soumission

4 avril 2014

Première soumission répondant aux critères de contrôle qualité

4 avril 2014

Première publication (Estimation)

8 avril 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 janvier 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 novembre 2016

Dernière vérification

1 novembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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