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

2016년 11월 18일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

535

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 이보두탄트 10mg
1일 1회 투여하는 경구 정제.
다른 이름들:
  • 코드: MEN 15596
위약 비교기: 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.
의약품: Placebo
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
다른 이름들:
  • 설탕 알약

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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).
기간: 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).
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Menarini Group

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 3월 1일

기본 완료 (실제)

2015년 6월 1일

연구 완료 (실제)

2015년 6월 1일

연구 등록 날짜

최초 제출

2014년 4월 4일

QC 기준을 충족하는 최초 제출

2014년 4월 4일

처음 게시됨 (추정)

2014년 4월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 18일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

이보두탄트 10mg에 대한 임상 시험

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