Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Elobixibat tablet: Elobixibat tablet (10 mg once daily as two tablets of 5 mg) before Breakfast for 2 weeks
Control Intervention1: Matching placebo of Elobixibat tablet: Matching placeb
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of 18-65 years age 2. Ambulatory patients with chronic constipation (fulfilling Rome IV criteria) reporting - Straining during more than 25% of defecations - Lumpy or hard stools more than 25% of defecations - Sensation of incomplete evacuation more than 25% of defecations 3. Patients with less than 3 SBM per week during pretreatment period. 4. Willing to comply with protocol requirements and sign a statement of informed consent 5. Willing to discontinue any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories) 6. Agreed to refrain from making any new, major life-style changes that may have affected CIC symptoms (e.g., starting a new diet or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit. 7. Female subjects of: Child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period (acceptable methods include intrauterine device, barrier or abstinence). OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). OR Postmenopausal for at least 1 year
Exclusion criteria
Exclusion criteria: 1. Pregnant, breast feeding, or planning a pregnancy 2. Subject of any age with evidence of clinically significant weight loss, anemia, or rectal bleeding and without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within 2 years period prior to screening. 3. Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of bowel movements. 4. Reported a Bristol Stool Form Scale score of 6 (loose, mushy stools) for > 1 SBM or a Bristol Stool Form Scale score of 7 (watery stools) with any SBM over the 2 weeks pretreatment period before the Randomization Visit. 5. Received a diagnosis of inflammatory bowel disease (IBD) 6. Meet the Rome IV criteria for Irritable Bowel Syndrome (IBS) or the Rome IV criteria for Opioid-Induced Constipation (OIC) 7. Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility. 8. Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, mega colon, mega rectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer. 9. Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer 10. Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy) 11. Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis 12. Has a potential central nervous system (CNS) cause of constipation 13. Has intestinal/rectal prolapse or other known pelvic floor dysfunction 14. Commonly uses digital maneuvers (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement 15. Has a history of diabetic neuropathy 16. Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit, surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit, an appendectomy or cholecystectomy during the 60 days before the Screening Visit, other major surgery during the 30 days before the Screening Visit. 17. Has a history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix 18. Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection 19. Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening 20. History of alcohol or drug abuse during the 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)Timepoint: Week 1 And Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Stool consistency using Bristol Stool Form ScaleTimepoint: Week 1 and week 2;Change from Baseline in Weekly Abdominal Bloating ScoreTimepoint: Week 1 And Week 2;Change from Baseline in Weekly Abdominal Discomfort ScoreTimepoint: Week 1 And Week 2;Change from Baseline in Weekly Degree of Straining of Spontaneous Bowel MovementTimepoint: Week 1 And Week 2;Median time to first Spontaneous Bowel MovementTimepoint: First timepoint to Spontaneous Bowel Movement;Proportion of patients with a Spontaneous Bowel Movement within 24 h after the first dose of study drugTimepoint: With in 24 hour;Proportion of patients with complete spontaneous bowel movement (CSBM)Timepoint: Week 1 And Week 2 | — |
Countries
India
Contacts
Public ContactVipul Modh
Dr. Reddy’s Laboratories Limited
Outcome results
None listed