Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation

Exclusion Criteria

• •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 BMs
• •The patient reports a BSFS of 6 or 7 during the Pretreatment Period
• •Has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms
• •Has a structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility
• •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, megacolon, megarectum, 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
• •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
• •Has a potential central nervous system (CNS) cause of constipation (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis)
• •Has intestinal/rectal prolapse or other known pelvic floor dysfunction
• •Commonly uses digital maneuvers (perianal pressure or digital disimpaction) or vaginal splinting to facilitate the passage of a bowel movement
• •Has a history of diabetic neuropathy
• •Has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
• •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
• •Known human immunodeficiency virus (HIV) or Hepatitis B/C (HBV/HCV) infection
• •Has a history of hospitalization for any psychiatric disorder, or any suicide attempt in the 2 years prior to Screening
• •Is actively abusing alcohol or drugs or has a history of alcohol or drug abuse during the 6 months prior to Screening
• •Is being treated for hypothyroidism, but the dose of medication has not been stable for at least 3 months at the time of Screening
• •Is a pregnant, breast-feeding, or lactating woman