Health Condition 1: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Intervention1: Eluxadoline tablets 100 mg and matching placebo of Mebeverine: The recommended dosage of Eluxadoline tablets in adults is 100 mg twice daily to be taken with food for 12 weeks.
Control
Sponsors
Sun Pharmaceutical Industries Limited
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, age between 18 to 65 years (both inclusive) and willing to provide written informed consent 2. Patient has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhoea as per Rome IV criteria 3. Patient has completed the patient diary on at least 11 of the 14 days during the 2 weeks prior to Randomization 4. 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] 5. 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]
Exclusion criteria
Exclusion criteria: 1. Patient has a diagnosis of other subtypes of IBS [e.g., constipation-predominant IBS, mixed IBS, or unclassified IBS] 2. Prior history of inflammatory or immune-mediated gastrointestinal (GI) disorders 3 Patients with history of other GI disorders 4. Patients with history or current symptoms of colon cancer 5. 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 6. Patients with history of pancreatitis of any etiology or with documented diagnosis of acute pancreatitis 7. Patients with history or current evidence of laxative abuse within 5 years prior to Screening 8. 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 9. Patients with history of lactose intolerance 10. Patients unable to swallow solid oral dosage forms 11. Patients with documented (microbiological report) lower GI infection within 3 months prior to Screening 12. Patients with uncontrolled hypertension at Screening and Randomization 13. Patients with anaemia at Screening 14. Patients with uncontrolled thyroid disorders 15. Patients with history of stroke, thrombotic event, myocardial infarction, or congestive heart failure (CHF) within 6 months prior to Screening 16. 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 17. Patients with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection 18. Patient having hypersensitivity to the study medication or medications of similar chemical classes or to any of its components 19. Patients with history of taking any serotonin (5HT3) antagonists (e.g., ondansetron, granisetron) within 14 days prior to Randomization 20. 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 21. Patients taking rifaximin or any other antibiotics (except topical antibiotics) 22. Patients taking antidepressants within 3 months prior to Screening 23. Patients taking analgesics for chronic migraine within 1 month prior to Screening 24. Patients with history of any malignancy within 5 years of Screening 25. Patient with any surgery planned during the study period 26. 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 27. Patient with history of participation in another clinical trial in the past 3 months of Screening 28. Employee of the Sponsor or Investigator or study center with direct involvement in the proposed study or other studies u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of composite responders based on improvements from baseline in worst abdominal pain (WAP) and stool consistency score (using BSFS) [Time frame: Week 12]Timepoint: Up to 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TEAEsTimepoint: Throughout the study period;Percentage of composite responders based on improvements from baseline in worst abdominal pain and stool consistency score (using BSFS)Timepoint: up to 8 weeks;Percentage of responders based on improvements from baseline in BSFS scoreTimepoint: Up to 12 weeks;Change from baseline in BSFS scoreTimepoint: Up to 12 weeks.;Percentage of responders based on improvements from baseline in worst abdominal painTimepoint: Up to 12 weeks.;Change from baseline in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) total scoreTimepoint: Up to 12 weeks.;Change from baseline in Daily Abdominal Discomfort scoreTimepoint: Up to 12 weeks.;Change from baseline in Daily Abdominal Bloating scoreTimepoint: Up to 12 weeks.;Change from baseline in stool frequency per dayTimepoint: Up to 12 weeks.;Change from baseline in number of bowel incontinence episodesTimepoint: Up to 12 weeks.;Change from baseline in number of urgency episodesTimepoint: Up to 12 weeks.;Change from baseline in Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL)scale total scoreTimepoint: Up to 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Ltd
Outcome results
None listed