NCT03099785已完成2 期
A Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled, Proof of Concept Study of Efficacy and Safety of Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 29
- 主要终点
- Proportion of subjects with relief from abdominal pain and improved stool consistency.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered two to three times daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent: signed written informed consent before inclusion in the study
- •Sex and Age: males/females, ≥18 year old
- •IBS Diagnosis: confirmed IBS-D diagnosis per Rome IV criteria
- •Symptoms: active symptoms of IBS at baseline (day 1) as measured by average daily scores for at least 7 days before baseline:
- •abdominal pain score ≥3 using an 11-point numeric rating scale and
- •bloating score: 2-4 inclusive and
- •stool consistency: score 6 or 7 (measured by the Bristol stool form scale) for at least 2 days from day -7 to day -1
- •and by a negative response to the global IBS symptom assessment question and to the IBS-related bloating assessment question both given weekly during the screening phase up to day 1 before randomisation:
- •"In the past 7 days, have you had adequate relief of your IBS symptoms?" [No] and
- •"In the past 7 days, have you had adequate relief of your IBS symptom of bloating?"[No]
- •Colonoscopy: performed within 5 years; if patient's age >50, colonoscopy performed within 2 years
- •Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the study
- •Literacy: sufficiently literate to comply with the study requirement of using electronic diaries and filling in electronic forms
- •Contraception and fertility: females of childbearing potential and fertile males must be using at least one reliable method of contraception.
- •Reliable methods of contraception for women include:
- •Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- •Reliable methods of contraception for men and male partners of female patients include:
- •Male condoms with spermicide
- •Reliable methods of contraception for both women and men include:
- •A sterile sexual partner or sexual abstinence Women of non-childbearing potential or in post-menopausal status for at least 1 year and sterile or surgically sterilised men will be admitted.
- •For women of childbearing potential, serum pregnancy test result must be negative at screening
排除标准
- •IBS: symptoms of constipation at baseline:
- •less than 3 bowel movements a week and
- •stool consistency score ≤2 for ≥2 days in a week
- •Screening phase: failure to record the daily symptom assessments in the diary cards for at least 7 days before baseline
- •Gastroenteric: underlying gastrointestinal diseases including ulcerative colitis, Crohn's disease, pancreatitis, any active infectious, haemorrhagic or inflammatory disorder not related to IBS-D, gastrointestinal motility disorders such as ileus, gastroparesis or pseudoobstruction, gastroduodenal ulcer, gastrointestinal malignancy or potentially fatal diseases if not full in remission (5 years from diagnosis and without maintenance treatment), amyloidosis and cholelithiasis if cholecystectomy not performed
- •Intolerance: ascertained underlying lactose intolerance with response to diet or any other malabsorption syndrome with the exclusion of asymptomatic lactose malabsorption
- •Coeliac disease: ascertained or presumptive underlying coeliac disease
- •Bile: ascertained or presumptive bile acid malabsorption or bile acid induced diarrhoea
- •Diabetes: underlying diabetes type I or II
- •Thyroid: abnormal thyroid function not controlled by thyroid medications
- •Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •Renal function: ascertained or presumptive clinically significant renal insufficiency or creatinine above twice the upper limit of normal (ULN) of the performing laboratory reference range
- •Liver function: chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT or total bilirubin >1.5 times ULN
- •AIDS/HIV: ascertained or presumptive acquired immunodeficiency (AIDS) or known infection with human immunodeficiency virus (HIV)
- •Diseases: significant history of medical or surgical conditions excluding hysterectomy, caesarean section, appendectomy, cholecystectomy, benign polypectomy and inguinal hernia and including renal, hepatic, cardiovascular, haematological, endocrine, immune, psychiatric or neurological diseases that in the investigator's opinion may interfere with the aim of the study; malignant diseases not in remission for at least 5 years
- •Medications: alosetron, eluxadoline, ondansetron, tegaserod, lubiprostone, warfarin, antipsychotic, antispasmodic, prokinetic, antidiarrhoeal, laxative, probiotic, narcotic or antibiotic agents within 14 days before the screening visit; antidepressant agents of the selective serotonin-reuptake inhibitor and tricyclic classes unless taken at a stable dose for at least 6 weeks before the screening visit
- •Investigational drugs: participation in the evaluation of any investigational product within 30 days before this study
- •Drug and alcohol: known history of drug or alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015] abuse
- •Pregnancy (females only): pregnant or lactating women or wishing to become pregnant in the 3 months following this visit
研究组 & 干预措施
Treatment group 1: dose regimen 1
Active Comparator
Rifamycin SV-MMX® 600 mg modified release tablets, three times daily (t.i.d.)
干预措施: Rifamycin SV 600mg t.i.d. (Drug)
Treatment group 2: dose regimen 2
Active Comparator
Rifamycin SV-MMX® 600 mg modified release tablets, two times daily (b.i.d.) + matching placebo daily (q.d.)
干预措施: Rifamycin SV b.i.d. + Placebo (Drug)
Treatment group 3: matching placebo
Placebo Comparator
Rifamycin SV-MMX® matching placebo tablets, t.i.d.
干预措施: Placebo t.i.d. (Drug)
结局指标
主要结局
Proportion of subjects with relief from abdominal pain and improved stool consistency.
时间窗: 88 days
Proportion of weekly responders defined as subjects who weekly have relief of the composite of abdominal pain and stool consistency, on the basis of their daily assessments. Relief of abdominal pain is defined as a decrease in the weekly average of abdominal pain score of at least 30% compared with baseline and relief of stool consistency is defined as a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. All participants will complete daily assessments of abdominal pain and stool consistency: * Abdominal Pain: Scored between 0 (no pain) and 10 (as bad as it could be) * Stool Consistency: Bristol Stool Scale (Scored 1-7)
次要结局
- Proportion of subjects with monthly relief of global IBS symptoms [Efficacy](88 days)
- Proportion of subjects with relief of IBS-related bloating during weeks 3-12 [Efficacy](10 weeks)
- Proportion of subjects with monthly relief of IBS-related bloating [Efficacy](88 days)
- Proportion of subjects with weekly relief of IBS symptoms, bloating and abdominal pain [Efficacy](88 days)
- Number of weeks of IBS-symptom relief during follow-up [Efficacy](10 weeks)
- Number of weeks of bloating relief during follow-up [Efficacy](10 weeks)
- Change in IBS-symptoms, bloating and abdominal pain from baseline to 12 weeks - captured by a daily diary [Efficacy](12 weeks)
- Proportion of subjects with relief of global IBS symptoms during weeks 3-12 [Efficacy](10 weeks)
- Proportion of monthly responders for IBS-symptoms, bloating and abdominal pain [Efficacy](3 months)
- Change from baseline to each week during follow up for IBS-symptoms bloating, abdominal pain, stool consistency, urgency - captured by a daily diary [Efficacy](12 weeks)
- Change from baseline at weeks 4, 8 and 12 in quality of life assessment [Efficacy](12 weeks)
研究者
研究点 (29)
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