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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. november 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

535

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Ibodutant 10 mg
Oral tablet, der skal gives én gang dagligt.
Andre navne:
  • Kode: MEN 15596
Placebo komparator: 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.
Medicin: Placebo
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
Andre navne:
  • Sukker pille

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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).
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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).
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Menarini Group

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

4. april 2014

Først indsendt, der opfyldte QC-kriterier

4. april 2014

Først opslået (Skøn)

8. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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