26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.

Key facts

Study ID

NCT01827592

Run by

Ferring Pharmaceuticals

People needed

376

Starts

2013-04-01

Expected to finish

2014-05-01

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 GI tract or a disease or condition that can affect Gastrointestinal (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 manoeuvres (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

• G and L Research, LLC — Foley, Alabama, United States
• Adobe Gastroenterology Research, LLC — Tucson, Arizona, United States
• Skyline Research LLC — Cerritos, California, United States
• GW Research, Inc. — Chula Vista, California, United States
• Paradigm Clinical, Inc. — Garden Grove, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Pulmonary Associates of Brandon — Brandon, Florida, United States
• In Vivo Clinical Research, Inc. — Hialeah, Florida, United States
• Medsearch Professional Group, Inc. — Hialeah, Florida, United States
• The Community Research of South Florida — Hialeah, Florida, United States
• Center for Gastrointestinal Disorders — Hollywood, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• Gastroenterology and Hepatology Associates — Jacksonville, Florida, United States
• Jupiter Research Inc. — Jupiter, Florida, United States
• Center for Advanced Gastroenterology — Maitland, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Georgia Clinical Research — Snellville, Georgia, United States
• Elite Clinical Trials, Inc. — Blackfoot, Idaho, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• MidAtlantic Medical Research Centers, Philip J. Bean Medical Center — Hollywood, Maryland, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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