Effect of Eluxadoline in Comparison to Mebeverine for Treatment of Patients With Diarrhoea-Predominant Irritable Bowel Syndrome

Phase 3

• Conditions: Health Condition 1: K580- Irritable bowel syndrome with diarrhea

• Registration Number: CTRI/2024/02/062593
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified