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临床试验/EUCTR2010-018300-85-DE
EUCTR2010-018300-85-DE进行中（未招募）不适用

Double-blind, randomised, placebo-controlled, parallel-group phase II study to evaluate the effect of oral ibodutant in irritable bowel syndrome with diarrhoea (IBS-D) - The Iris-2 Study. - IRIS-2

Menarini Ricerche S.p.A.0 个研究点目标入组 1,220 人开始时间: 2010年5月26日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
1,220
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Patients meeting the following criteria will be eligible for entry into the study and start the run-in period:
  • •1. Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the following symptom-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.
  • •2. Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before Screening (Day -14).
  • •3. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
  • •4. For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period and up to 30 days post-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous 6 months.
  • •5. Normal physical examination or without clinically relevant abnormalities.
  • •Additional Inclusion Criteria at Randomisation (after a 2-week treatment-free run-in period with symptom-collection by IVRS/IWRS diary)
  • •Patients’ diary records during the run-in period showing:
  • •- at least 25% of the bowel movements with loose or watery (Bristol Stool Scale 6 or 7) consistency AND less than 25% of bowel movements with hard or lumpy (Bristol Stool Scale 1 or 2) consistency,
  • •- at least one bowel movement on each day,
  • •- weekly average of at least 3 bowel movements per day (during both weeks of the run-in period),
  • •- abdominal pain/discomfort of at least moderate (grade 2) severity at least 3 days per week (during both weeks of the run-in period).
  • •Adequate compliance with the IVRS/IWRS diary recording procedure (> 75% of the nominal daily entry expected during both weeks of the run-in period).
  • •No use of prohibited concurrent medication. NOTE: No short-term use of the antidiarrhoeal loperamide is allowed during the run-in period.
  • •No clinically relevant abnormalities in laboratory findings and/or 12-lead ECG performed at Screening.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range
  • •Patients meeting the following criteria will be eligible for entry into the study and start the run-in period:
  • •1. Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the following symptom-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.
  • •2. Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before Screening (Day -14).
  • •3. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
  • •4. For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period and up to 30 days post-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous 6 months.
  • •5. Normal physical examination or without clinically relevant abnormalities.
  • •Additional Inclusion Criteria at Randomisation (after a 2-week treatment-free run-in period with symptom-collection by IVRS/IWRS diary)
  • •Patients’ diary records during the run-in period showing:
  • •- at least 25% of the bowel movements with loose or watery (Bristol Stool Scale 6 or 7) consistency AND less than 25% of bowel movements with hard or lumpy (Bristol Stool Scale 1 or 2) consistency,
  • •- at least one bowel movement on each day,
  • •- weekly average of at least 3 bowel movements per day (during both weeks of the run-in period),
  • •- abdominal pain/discomfort of at least moderate (grade 2) severity at least 3 days per week (during both weeks of the run-in period).
  • •Adequate compliance with the IVRS/IWRS diary recording procedure (> 75% of the nominal daily entry expected during both weeks of the run-in period).
  • •No use of prohibited concurrent medication. NOTE: No short-term use of the antidiarrhoeal loperamide is allowed during the run-in period.
  • •No clinically relevant abnormalities in laboratory findings and/or 12-lead ECG performed at Screening.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:
  • •1. Organic abnormalities of the GI tract, including history of colonic or major abdominal surgery, i.e. stomach, small/large bowel, or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery), current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission = 5 years), inflammatory bowel diseases, symptomatic gallbladder stone disease, complicated diverticulosis (i.e. diverticulitis), ectopic endometriosis.
  • •NOTE: Patients with alarm signs (e.g. fever, rectal bleeding, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
  • •2. History of gluten enteropathy.
  • •3. Lactose intolerance as assessed by response to diet.
  • •4. History of positive tests for ova or parasites, or occult blood in the stool in the previous 6 months.
  • •5. Previous diagnosis of diabetes mellitus (either type 1 or 2).
  • •6. Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable for at least the last 2 months.
  • •7. Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
  • •8. Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
  • •NOTE: dietary habits, lifestyle and exercise regimen must be maintained for the duration of the study
  • •9. Use of prohibited concurrent medication within 7 days prior to Screening, namely:
  • •- Antimuscarinic drugs.
  • •- Drugs enhancing GI motility such as prokinetic drugs (e.g. metoclopramide, cisapride, domperidone) or laxatives.
  • •- Analgesic drugs (opioids or non-steroidal anti-inflammatory drugs). NOTE: Short term use of paracetamol is allowed for max 2 consecutive days.
  • •- Antidepressants. NOTE: The use of a single antidepressants is only allowed when the drug type and its dose regimen has not been changed in the previous 6 months.
  • •- Benzodiazepines. NOTE: The use of a single benzodiazepine is only allowed when it is administered as sleep-inducer and the drug type and its dose regimen has not been changed in the previous 6 months.
  • •- Other medication for IBS. NOTE: The antidiarrhoeal loperamide must be discontinued 3 days prior to Screening.
  • •10. Pregnancy or breastfeeding.
  • •11. Hypersensitivity to the drug excipients.
  • •12. Patients not able to understand or collaborate throughout the study.
  • •13. Participation in other clinical studies in the previous 4 weeks.
  • •Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:
  • •1. Organic abnormalities of the GI tract, including history of colonic or major abdominal surgery, i.e. stomach, small/large bowel, or large vessel abdominal surgery (except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery), current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission = 5 years), inflammatory bowel diseases, symptomatic gallbladder stone disease, complicated diverticulosis (i.e. diverticulitis), ectopic endometriosis.
  • •NOTE: Patients with alarm signs (e.g. fever, rectal bleeding, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease.
  • •2. History of gluten enteropathy.
  • •3. Lactose intolerance as assessed by response to diet.
  • •4. History of positive tests for ova or parasites, or occult blood in the stool in the previous 6 months.
  • •5. Previous diagnosis of diabetes mellitus (either type 1 or 2).
  • •6. Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable for at least the last 2 months.
  • •7. Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
  • •8. Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
  • •NOTE: dietary habits, lifestyle and exercise regimen must be maintained for the duration of the study
  • •9. Use of prohibited concurrent medication within 7 days prior to Screening, namely:
  • •- Antimuscarinic drugs.
  • •- Drugs enhancing GI motility such as prokinetic drugs (e.g. metoclopramide, cisapride, domperidone) or laxatives.
  • •- Analgesic drugs (opioids or non-steroidal anti-inflammatory drugs). NOTE: Short term use of paracetamol is allowed for max 2 consecutive days.
  • •- Antidepressants. NOTE: The use of a single antidepressants is only allowed when the drug type and its dose regimen has not been changed in the previous 6 months.
  • •- Benzodiazepines. NOTE: The use of a single benzodiazepine is only allowed when it is administered as sleep-inducer and the drug type and its dose regimen has not been changed in the previous 6 months.
  • •- Other medication for IBS. NOTE: The antidiarrhoeal loperamide must be discontinued 3 days prior to Screening.
  • •10. Pregnancy or breastfeeding.
  • •11. Hypersensitivity to the drug excipients.
  • •12. Patients not able to understand or collaborate throughout the study.
  • •13. Participation in other clinical studies in the previous 4 weeks.

研究者

发起方
Menarini Ricerche S.p.A.

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