Status:
TERMINATED
26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.
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 26-week Treatment Period in patients...
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 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01827592
Start Date
April 1 2013
End Date
May 1 2014
Last Update
October 20 2015
Active Locations (94)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
2
G and L Research, LLC
Foley, Alabama, United States
3
Adobe Gastroenterology Research, LLC
Tucson, Arizona, United States
4
Skyline Research LLC
Cerritos, California, United States