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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

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

Key facts

Study ID

NCT01833065

Run by

Ferring Pharmaceuticals

People needed

314

Starts

2013-04-01

Expected to finish

2014-04-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Straining during at least 25% of defecations
• Lumpy or hard stools during at least 25% of defecations
• 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

You may not qualify if…

• 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

Where it is running

• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• David Geffen School of Medicine at University of California, Los Angeles — Los Angeles, California, United States
• West Gastroenterology Associates — Los Angeles, California, United States
• Sacramento Research Medical Group — Sacramento, California, United States
• Precision Research Institute, LLC — San Diego, California, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Zasa Clinical Research — Boynton Beach, Florida, United States
• Meridien Research — Bradenton, Florida, United States
• Sanitas Research — Coral Gables, Florida, United States
• Lake Internal Medicine Associates — Eustis, Florida, United States
• Health Care Family Rehab Corp. — Hialeah, Florida, United States
• Southeast Clinical Research, LLC — Jacksonville, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Southeast Regional Research Group — Columbus, Georgia, United States
• Premier Healthcare Research, LLC — Evanston, Illinois, United States
• Rockford Gastroenterology Associates, Ltd. — Rockford, Illinois, United States
• Heartland Research Associates, LLC — Augusta, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Professional Research Network of Kansas, LLC — Witchita, Kansas, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Beacon Clinical Research, LLC — Brockton, Massachusetts, United States
• Birmingham Gastroenterology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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