CTRI/2024/02/062593尚未招募3 期
A Prospective, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of Eluxadoline in Comparison to Mebeverine for Treatment of Patients With Diarrhoea-Predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 356
- 试验地点
- 25
- 主要终点
- Percentage of composite responders based on improvements from baseline in worst abdominal pain (WAP) and stool consistency score (using BSFS) [Time frame: Week 12]
研究概览
简要总结
This study will be a prospective, multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled phase III, comparative study. The study will be conducted at approximately 15 to 20 centers in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval.
Screening period:
The patient will be screened only after obtaining written informed consent. After obtaining consent, the patients will undergo a screening period of minimum 2 weeks and maximum 3 weeks. At screening visit, study-specific screening (including inclusion and exclusion criteria, medical and medication history, demography, vitals, physical and laboratory examination, 12-Lead ECG) will be performed.
After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will be given study products Eluxadoline 100 mg tablets and matching placebo of Mebeverine OR Mebeverine 200 mg prolonged-release capsules and matching placebo of Eluxadoline orally twice daily. During the study, assessments will be performed as planned in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, age between 18 to 65 years (both inclusive) and willing to provide written informed consent
- •Patient has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhoea as per Rome IV criteria
- •Patient has completed the patient diary on at least 11 of the 14 days during the 2 weeks prior to Randomization
- •Women of childbearing potential must have a negative urine pregnancy test and should be non-lactating before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of the study (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices (IUDs), intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
- •Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period].
排除标准
- •Patient has a diagnosis of other subtypes of IBS [e.g., constipation-predominant IBS, mixed IBS, or unclassified IBS]
- •Prior history of inflammatory or immune-mediated gastrointestinal (GI) disorders 3 Patients with history of other GI disorders
- •Patients with history or current symptoms of colon cancer
- •Patients with any of the following surgical history: a.
- •Cholecystectomy with ANY history of post cholecystectomy biliary tract pain b.
- •Any abdominal surgery within the 3 months prior to Screening
- •Patients with history of pancreatitis of any etiology or with documented diagnosis of acute pancreatitis
- •Patients with history or current evidence of laxative abuse within 5 years prior to Screening
- •Patients with inadequate hepatic function [(total bilirubin ≥1.5 X ULN) or aspartate transaminase (AST) ≥3 X ULN or alanine transaminase (ALT) ≥3 X ULN] or inadequate renal function [creatinine clearance (CrCL) by Modification of Diet in Renal Disease (MDRD) formula ≤60 ml/min/1.73 m2] at Screening
- •Patients with history of lactose intolerance
- •Patients with documented (microbiological report) lower GI infection within 3 months prior to Screening
- •Patients with uncontrolled hypertension at Screening and Randomization
- •Patients with anaemia at Screening
- •Patients with history of stroke, thrombotic event, myocardial infarction, or congestive heart failure (CHF) within 6 months prior to Screening
- •Patients with history of any clinically significant disorder involving hepatic, cardiovascular, renal, pulmonary, metabolic, hematologic, psychiatric condition or any other clinically significant condition requiring treatment which at the investigator’s discretion might interfere with the study
- •Patients with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
- •Patient having hypersensitivity to the study medication or medications of similar chemical classes or to any of its components
- •Patients with history of taking any serotonin (5HT3) antagonists (e.g., ondansetron, granisetron) within 14 days prior to Randomization
- •Patients taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDS) or any other narcotics or any opioid containing agents or antacids containing aluminum/ magnesium or antidiarrhoeal agent or antiemetic agents or antispasmodic agents or bismuth or prokinetic agents
- •Patients taking rifaximin or any other antibiotics (except topical antibiotics)
- •Patients taking antidepressants within 3 months prior to Screening
- •Patients taking analgesics for chronic migraine within 1 month prior to Screening
- •Patients with history of any malignancy within 5 years of Screening
- •Patient with history of nicotine and/or alcohol and/or any other substance abuse as per DSM-5 criteria within last 2 years prior to Screening
- •Patient with history of participation in another clinical trial in the past 3 months of Screening
- •Employee of the Sponsor or Investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
结局指标
主要结局
Percentage of composite responders based on improvements from baseline in worst abdominal pain (WAP) and stool consistency score (using BSFS) [Time frame: Week 12]
时间窗: Up to 12 weeks.
次要结局
- Percentage of composite responders based on improvements from baseline in worst abdominal pain and stool consistency score (using BSFS)(up to 8 weeks)
- Percentage of responders based on improvements from baseline in BSFS score(Up to 12 weeks)
- Change from baseline in BSFS score(Up to 12 weeks.)
- Percentage of responders based on improvements from baseline in worst abdominal pain(Up to 12 weeks.)
- Change from baseline in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) total score(Up to 12 weeks.)
- Change from baseline in Daily Abdominal Discomfort score(Up to 12 weeks.)
- Change from baseline in Daily Abdominal Bloating score(Up to 12 weeks.)
- Change from baseline in stool frequency per day(Up to 12 weeks.)
- Change from baseline in number of bowel incontinence episodes(Up to 12 weeks.)
- Change from baseline in number of urgency episodes(Up to 12 weeks.)
- Change from baseline in Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL)scale total score(Up to 12 weeks.)
- Incidence of TEAEs(Throughout the study period)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (25)
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