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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 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

535

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Compressa orale, da somministrare una volta al giorno.
Altri nomi:
  • Codice: UOMO 15596
Comparatore 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.
Droga: Placebo
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
Altri nomi:
  • Pillola di zucchero

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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).
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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).
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Menarini Group

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2014

Completamento primario (Effettivo)

1 giugno 2015

Completamento dello studio (Effettivo)

1 giugno 2015

Date di iscrizione allo studio

Primo inviato

4 aprile 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 aprile 2014

Primo Inserito (Stima)

8 aprile 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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