Status:
TERMINATED
Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.
Detailed Description
The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 12-week Treatment Period followed by...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT01833065
Start Date
April 1 2013
End Date
April 1 2014
Last Update
October 20 2015
Active Locations (97)
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1
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, United States
2
Genova Clinical Research, Inc.
Tucson, Arizona, United States
3
Preferred Research Partners
Little Rock, Arkansas, United States
4
Arkansas Gastroenterology
North Little Rock, Arkansas, United States