Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Elobixibat 10 mg/day; Elobixibat 5 mg/day; Placebo
Intervention description: Elobixibat 10 mg/day; Elobixibat 5 mg/day; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with
      Chronic Idiopathic Constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) ≥18.5 but <35.0 kg/m^2

          -  Male or female ≥18 years of age

          -  Reports <3 spontaneous Bowel Movements (BM) per week and reports one or more of the
             following symptoms for the last 3 months with symptom onset at least 6 months before
             the Screening Visit or before starting chronic therapy with any laxative:

               1. Straining during at least 25% of defecations

               2. Lumpy or hard stools during at least 25% of defecations

               3. Sensation of incomplete evacuation during at least 25% of defecations

          -  Is ambulatory and community dwelling

          -  An initial colonoscopy is required if recommended by national guidelines

        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