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

NCT ID: NCT01827592

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-05-31

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.

Conditions

Chronic Idiopathic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EBX 10

Elobixibat 10 mg/day

Group Type: EXPERIMENTAL

Elobixibat 10 mg

Intervention Type: DRUG

Elobixibat 10 mg/day

EBX 5

Elobixibat 5 mg/day

Group Type: EXPERIMENTAL

Elobixibat 5 mg

Intervention Type: DRUG

Elobixibat 5 mg/day

PLCBO

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Elobixibat 10 mg

Elobixibat 10 mg/day

Intervention Type: DRUG

Elobixibat 5 mg

Elobixibat 5 mg/day

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

A3309; A3309

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

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

Boston Clinical Trials

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Midwest Gastroenterology Partners

Lee's Summit, Missouri, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

ActivMed Practices and Research, Inc.

Newington, New Hampshire, United States

HOSC, Inc.

Brooklyn, New York, United States

North American Partners in Pain Management

Valley Stream, New York, United States

Carolina Digestive Health Associates, PA

Davidson, North Carolina, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Gastroenterology Research Consultants of Greater Cincinnati

Cincinnati, Ohio, United States

Hometown Urgent Care and Occupational Health

Groveport, Ohio, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

Mainline Gastroenterology Associates

Souderton, Pennsylvania, United States

ClinSearch

Chattanooga, Tennessee, United States

Memphis Gastroenterology Group, PC

Germantown, Tennessee, United States

KRK Medical Research

Dallas, Texas, United States

Research Across America

Dallas, Texas, United States

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Pioneer Research Solutions, Inc.

Sugar Land, Texas, United States

Northwest Gastroenterology Associates

Bellevue, Washington, United States

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Huisartspraktijk Jaak Mortelmans

Ham, , Belgium

Universitair Ziekenhuis Leuven

Leuven, , Belgium

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina do ABC

Sant André, São Paulo, Brazil

Escola Paulista de Medicina, Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

John Buhler Research Center

Winnipeg, Manitoba, Canada

Maritime Medical Research Center

Bathurst, New Brunswick, Canada

Prime Health Clinical Research Organization

Toronto, Ontario, Canada

Alpha Clinical Research LLC

Québec, Quebec, Canada

Rhodin Recherche Clinique

DrummondvilleQC, , Canada

Derma Plus s.r.o.

České Budějovice, , Czechia

Gastroenterologie, s. r. o.

Hradec Králové, , Czechia

Nemocnice Valasske Mezirici a.s., Gastroenterologicka ambulance

Valašské Meziříčí, , Czechia

Klinikum der Universität München-Großhadern

München, Bavaria, Germany

Israelitisches Krankenhaus Hamburg

Hamburg, City state of Hamburg, Germany

Synexus Clinical Research GmbH

Frankfurt am Main, Hesse, Germany

Elbe Klinikum Stade - Buxtehude GmbH

Stade, Lower Saxony, Germany

Synexus Clinical Research GmbH

Bochum, North Rhine-Westphalia, Germany

Synexus Clinical Research GmbH

Leipzig, Saxony, Germany

Emovis GmbH

Berlin, State of Berlin, Germany

Synexus Clinical Research GmbH

Berlin, State of Berlin, Germany

Universitätsklinik Charité, Campus Mitte

Berlin, State of Berlin, Germany

Soroka University Medical Center

Beersheba, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Hadassah Medical Organization, Ein Kerem

Jerusalem, , Israel

Kaplan Medical Center

Rehovot, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Assaf Harofeh Medical Centre

Ẕerifin, , Israel

Szpital Wojewódzki w Opolu

Opole, Opole Voivodeship, Poland

Centrum Medyczne sw. Lukasza Sp. z o.o.

Częstochowa, Silesian Voivodeship, Poland

Neuro-Care NZOZ

Katowice, Silesian Voivodeship, Poland

Pomorski Uniwersytet Medyczny

Szczecin, West Pomeranian Voivodeship, Poland

SPZOZ Uniwersytecki Szpital Kliniczny nr 5 im. Gen. Dyw. B. Szareckiego, Uniwersytetu Medycznego

Lódz, Łódź Voivodeship, Poland

Global Clinical Trials

Port Elizabeth, Eastern Cape, South Africa

Boanerges Clinical Research

Bloemfontein, Free State, South Africa

Synexus Clinical Research SA

Pretoria, Gauteng, South Africa

Parklands Medical Centre

Durban, KwaZulu-Natal, South Africa

Boland Ethical Research Group

Worcester, Western Cape, South Africa

The Memory Centre

Johannesburg, , South Africa

Langeberg Clinical Trials

Kraaifontein, , South Africa

Newtown Clinical Research Centre

Newtown, , South Africa

Synexus Midlands Clinical Research Centre

Birmingham, England, United Kingdom

County Durham and Darlington NHS Foundation Trust

Durham, England, United Kingdom

Synexus Manchester Clinical Research Centre

Manchester, England, United Kingdom

Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Synexus Wales Clinical Research Centre

Cardiff, Wales, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Countries

United States; Belgium; Brazil; Canada; Czechia; Germany; Israel; Poland; South Africa; United Kingdom

Other Identifiers

2012-005587-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000079

Identifier Type: -

Identifier Source: org_study_id