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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

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