12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) (IRIS-3)
2016年11月18日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
535
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kaluga、俄罗斯联邦、248007
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Moscow、俄罗斯联邦、115446
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Saint-Petersburg、俄罗斯联邦、196247
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Smolensk、俄罗斯联邦、214019
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St. Petersburg、俄罗斯联邦、194295
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St.Petersburg、俄罗斯联邦、193015
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Yaroslavl、俄罗斯联邦、150000
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Haskovo、保加利亚、6300
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Plovdiv、保加利亚、4002
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Ruse、保加利亚、7002
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Sofia、保加利亚、1431
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Sofia、保加利亚、1407
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Veliko Tarnovo、保加利亚、5000
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Berlin、德国、10629
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Berlin、德国、13125
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Essen、德国、45355
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Hamburg、德国、22297
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Hamburg、德国、20253
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Baden-Wuerttemberg
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Stuttgart、Baden-Wuerttemberg、德国、70593
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Bari、意大利、70124
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Bari、意大利、70100
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Bologna、意大利、40138
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Florence、意大利、50139
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Pavia、意大利、27100
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Rome、意大利、00168
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Karlovy Vary、捷克共和国、360 66
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Prague、捷克共和国、14021
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Prague、捷克共和国、19000
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Usti nad Labem、捷克共和国、401 13
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Usti nad Orlici、捷克共和国、562 01
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Bordeaux、法国、33000
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NICE Cedex、法国、06202
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Nantes Cedex、法国、44093
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Rouen、法国、76031
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Ile-de-France
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Bobigny、Ile-de-France、法国、93000
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Bydgoszcz、波兰、85-168
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Czestochowa、波兰、42-200
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Krakow、波兰、31009
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Lublin、波兰、20-090
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Wroclaw、波兰、53333
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Brasov、罗马尼亚、500326
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Brasov、罗马尼亚、500283
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Bucharest、罗马尼亚、50098
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Bucharest、罗马尼亚、20125
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Jud. Mures
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Targu Mures、Jud. Mures、罗马尼亚、540461
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Mures
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Tirgu Mures、Mures、罗马尼亚、540098
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Timis
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Timisoara、Timis、罗马尼亚、300168
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Timisoara、Timis、罗马尼亚、300193
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Alabama
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Huntsville、Alabama、美国、35802
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Arizona
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Sherwood、Arizona、美国、72120
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Arkansas
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Little Rock、Arkansas、美国、72205
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California
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Artesia、California、美国、90701
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Chula Vista、California、美国、91910
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Encino、California、美国、91436
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Mission Hills、California、美国、91345
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Sacramento、California、美国、95821
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San Diego、California、美国、92123
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Upland、California、美国、91786
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Colorado
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Littleton、Colorado、美国、80127
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Connecticut
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Bristol、Connecticut、美国、06010
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Florida
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Boynton Beach、Florida、美国、33426
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Brandon、Florida、美国、33511
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Brooksville、Florida、美国、34601
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Coral Gables、Florida、美国、33134
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Gainesville、Florida、美国、32607
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Hialeah、Florida、美国、33012
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Jupiter、Florida、美国、33458
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Miami、Florida、美国、33165
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Miami、Florida、美国、33125
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Miami、Florida、美国、33175
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Miami、Florida、美国、33185
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Miami Lakes、Florida、美国、33014
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Illinois
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Addison、Illinois、美国、60101
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Chicago、Illinois、美国、60604
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Kansas
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Augusta、Kansas、美国、67010
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Newton、Kansas、美国、67114
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Wichita、Kansas、美国、67205
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Kentucky
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Lexington、Kentucky、美国、40509
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Madisonville、Kentucky、美国、42431
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Owensboro、Kentucky、美国、42303
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Louisiana
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Crowley、Louisiana、美国、70526
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Maryland
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Baltimore、Maryland、美国、21215
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Michigan
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Ann Arbor、Michigan、美国、48106
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Chesterfield、Michigan、美国、48047
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Saginaw、Michigan、美国、48604
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Troy、Michigan、美国、48098
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Nevada
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Las Vegas、Nevada、美国、89128
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New York
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Hartsdale、New York、美国、10530
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North Carolina
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Fayetteville、North Carolina、美国、28304
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Greensboro、North Carolina、美国、27408
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North Dakota
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Fargo、North Dakota、美国、58103
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Ohio
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Akron、Ohio、美国、44302
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Cincinnati、Ohio、美国、45242
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Cincinnati、Ohio、美国、45219
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Cleveland、Ohio、美国、44122
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Columbus、Ohio、美国、43214
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Dayton、Ohio、美国、45432
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Pennsylvania
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Reading、Pennsylvania、美国、19606
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South Carolina
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Greer、South Carolina、美国、29650
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Simpsonville、South Carolina、美国、29681
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Tennessee
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Chattanooga、Tennessee、美国、37421
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Knoxville、Tennessee、美国、37912
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Knoxville、Tennessee、美国、37919
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Nashville、Tennessee、美国、37205
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Smyrna、Tennessee、美国、37167
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Texas
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Beaumont、Texas、美国、77701
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Houston、Texas、美国、77089
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Houston、Texas、美国、77052
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Hurst、Texas、美国、76054
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San Antonio、Texas、美国、78229
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Ste. Channelview、Texas、美国、77530
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Utah
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West Jordan、Utah、美国、84088
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West Virginia
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Morgantown、West Virginia、美国、26505
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Leicestershire、英国、LE10 2SE
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Manchester、英国、M23 9LT
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Plymouth, Devon、英国、PL5 3JB
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Cornwall
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Penzance、Cornwall、英国、TR18 4JH
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Derbyshire
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Chesterfield、Derbyshire、英国、S40 4AA
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Scotland
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Inverness、Scotland、英国、IV2 4AG
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South Yorkshire
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Doncaster、South Yorkshire、英国、DN2 5LT
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Barcelona、西班牙、08035
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Barcelona、西班牙、08022
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Madrid、西班牙、28040
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Sevilla、西班牙、41013
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Barcelona
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Badalona、Barcelona、西班牙、08916
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Mataro、Barcelona、西班牙、8304
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Sabadell、Barcelona、西班牙、08208
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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:
- 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.
- Symptom-onset at least 6 months prior to diagnosis.
- 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.
- 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:
- 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.
- At least one bowel movement on each day.
- A weekly average of at least 3 bowel movements per day.
- 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.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
口服片剂，每日一次。
其他名称：
|
|
安慰剂比较：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.
|
Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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).
大体时间：12 weeks
|
The patient will be considered a weekly responder if she meets both of the following criteria in the same week:
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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).
大体时间：12 weeks
|
The patient will be considered a weekly abdominal pain responder if she meets the following criterion:
|
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).
大体时间：12 weeks
|
The patient will be considered a weekly stool consistency responder if she meets the following criterion:
|
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).
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Lin Chang, Professor、Digestive Health and Nutrition Clinic. University of California, Los Angeles, CA, USA
- 学习椅：Jan F Tack, Professor、Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年3月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2014年4月4日
首先提交符合 QC 标准的
2014年4月4日
首次发布 (估计)
2014年4月8日
研究记录更新
最后更新发布 (估计)
2017年1月19日
上次提交的符合 QC 标准的更新
2016年11月18日
最后验证
2016年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.