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

Ferring

Status and phase: Terminated; Phase 3

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: Elobixibat 10 mg/day; Drug: Elobixibat 5 mg/day; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01833065

000080 (Other Identifier)

2012-005588-28 (EudraCT Number)

Details and patient eligibility

About

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

Full 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 a 4-week Withdrawal Period in patients with chronic idiopathic constipation. During Withdrawal Period a sub-group of patients in elobixibat 5 mg and 10 mg treatment arms respectively received placebo treatment, while rest of the patients continued with 5 mg and 10 mg treatment in respective groups. In placebo groups, patients received elobixibat 10 mg treatment during Withdrawal Period. Patients were followed-up for 2 weeks after end of the Withdrawal Period.

The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of treatment period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the Withdrawal Period.

The trial was early terminated due to a distribution issue with the trial medication.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 3 patient groups, including a placebo group

EBX 10

Experimental group

Description:

Elobixibat 10 mg/day

Treatment:

Drug: Elobixibat 10 mg/day

EBX 5

Experimental group

Description:

Elobixibat 5 mg/day

Treatment:

Drug: Elobixibat 5 mg/day

PLCBO

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo