Clinical trial NCT01827592: 26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation
Official title: A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients With Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with chronic idiopathic constipation. Patients were followed-up for 2 weeks after end of the Treatment 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 treatment.

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

Eligibility criteria: 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 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

Primary outcomes:
measure: Overall Complete Spontaneous Bowel Movement (CSBM) Response
timeFrame: During the first 12 weeks
Secondary outcomes:
measure: Occurrence of CSBM Response
timeFrame: Within the first 24 hours of treatment initiation
measure: Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)
timeFrame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
measure: Change From Baseline in Weekly Stool Consistency of SBMs
timeFrame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
measure: Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder
timeFrame: At 12 weeks
measure: Change From Baseline in Weekly Degree of Straining of SBMs
timeFrame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
measure: Change From Baseline in Weekly Abdominal Bloating Score
timeFrame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
measure: Change From Baseline in Weekly Abdominal Discomfort Score
timeFrame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Foley
country: United States
facility: G and L Research, LLC
state: Alabama
city: Tucson
country: United States
facility: Adobe Gastroenterology Research, LLC
state: Arizona
city: Cerritos
country: United States
facility: Skyline Research LLC
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Garden Grove
country: United States
facility: Paradigm Clinical, Inc.
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Brandon
country: United States
facility: Pulmonary Associates of Brandon
state: Florida
city: Hialeah
country: United States
facility: In Vivo Clinical Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: Medsearch Professional Group, Inc.
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Center for Gastrointestinal Disorders
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Gastroenterology and Hepatology Associates
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research Inc.
state: Florida
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials, Inc.
state: Idaho
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Hollywood
country: United States
facility: MidAtlantic Medical Research Centers, Philip J. Bean Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Lee's Summit
country: United States
facility: Midwest Gastroenterology Partners
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Newington
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Brooklyn
country: United States
facility: HOSC, Inc.
state: New York
city: Valley Stream
country: United States
facility: North American Partners in Pain Management
state: New York
city: Davidson
country: United States
facility: Carolina Digestive Health Associates, PA
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Groveport
country: United States
facility: Hometown Urgent Care and Occupational Health
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Souderton
country: United States
facility: Mainline Gastroenterology Associates
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Ham
country: Belgium
facility: Huisartspraktijk Jaak Mortelmans
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Sant André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: São Paulo
country: Brazil
facility: Escola Paulista de Medicina, Universidade Federal de São Paulo
city: Winnipeg
country: Canada
facility: John Buhler Research Center
state: Manitoba
city: Bathurst
country: Canada
facility: Maritime Medical Research Center
state: New Brunswick
city: Toronto
country: Canada
facility: Prime Health Clinical Research Organization
state: Ontario
city: Québec
country: Canada
facility: Alpha Clinical Research LLC
state: Quebec
city: DrummondvilleQC
country: Canada
facility: Rhodin Recherche Clinique
city: Ceské Budejovice
country: Czech Republic
facility: Derma Plus s.r.o.
city: Hradec Králové
country: Czech Republic
facility: Gastroenterologie, s. r. o.
city: Valasske Mezirici
country: Czech Republic
facility: Nemocnice Valasske Mezirici a.s., Gastroenterologicka ambulance
city: München
country: Germany
facility: Klinikum der Universität München-Großhadern
state: Bavaria
city: Frankfurt am Main
country: Germany
facility: Synexus Clinical Research GmbH
state: Hessen
city: Stade
country: Germany
facility: Elbe Klinikum Stade - Buxtehude GmbH
state: Niedersachsen
city: Bochum
country: Germany
facility: Synexus Clinical Research GmbH
state: Nordrhein-westfalen
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
state: Sachsen
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH
city: Berlin
country: Germany
facility: Universitätsklinik Charité, Campus Mitte
city: Hamburg
country: Germany
facility: Israelitisches Krankenhaus Hamburg
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Ein Kerem
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Centre
city: Lódz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 5 im. Gen. Dyw. B. Szareckiego, Uniwersytetu Medycznego
state: Lodzkie
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu
state: Opolskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne sw. Lukasza Sp. z o.o.
state: Slaskie
city: Katowice
country: Poland
facility: Neuro-Care NZOZ
state: Slaskie
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny
state: Zachodniopomorskie
city: Port Elizabeth
country: South Africa
facility: Global Clinical Trials
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Boanerges Clinical Research
state: Free State
city: Pretoria
country: South Africa
facility: Synexus Clinical Research SA
state: Gauteng
city: Durban
country: South Africa
facility: Parklands Medical Centre
state: KwaZulu-Natal
city: Worcester
country: South Africa
facility: Boland Ethical Research Group
state: Western Cape
city: Johannesburg
country: South Africa
facility: The Memory Centre
city: Kraaifontein
country: South Africa
facility: Langeberg Clinical Trials
city: Newtown
country: South Africa
facility: Newtown Clinical Research Centre
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
state: England
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
state: England
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
state: England
city: Dundee
country: United Kingdom
facility: Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School
state: Scotland
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
state: Wales
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: