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

NCT01827592 | Terminated Phase 3 Results

• 2 other identifiers: 0000792012-005587-94
• Study Type: interventional
• Target: 376
• Locations: 10 countries
• Sites: 94

Brief Summary

Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• Overall Complete Spontaneous Bowel Movement (CSBM) Response

  This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.

  During the first 12 weeks

Secondary Outcomes (7)

• Occurrence of CSBM Response

  Within the first 24 hours of treatment initiation

• Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)

  From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

• Change From Baseline in Weekly Stool Consistency of SBMs

  From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

• Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder

  At 12 weeks

• Change From Baseline in Weekly Degree of Straining of SBMs

  From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

Study Arms (3)

EBX 10

EXPERIMENTAL

Elobixibat 10 mg/day

Drug: Elobixibat 10 mg

EBX 5

EXPERIMENTAL

Elobixibat 5 mg/day

Drug: Elobixibat 5 mg

PLCBO

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Elobixibat 10 mg DRUG

Elobixibat 10 mg/day

Also known as: A3309

EBX 10

Elobixibat 5 mg DRUG

Elobixibat 5 mg/day

Also known as: A3309

EBX 5

Placebo DRUG

Placebo

PLCBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (94)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Location

G and L Research, LLC

Foley, Alabama, United States

Location

Adobe Gastroenterology Research, LLC

Tucson, Arizona, United States

Location

Skyline Research LLC

Cerritos, California, United States

Location

GW Research, Inc.

Chula Vista, California, United States

Location

Paradigm Clinical, Inc.

Garden Grove, California, United States

Location

Providence Clinical Research

North Hollywood, California, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Location

Pulmonary Associates of Brandon

Brandon, Florida, United States

Location

In Vivo Clinical Research, Inc.

Hialeah, Florida, United States

Location

Medsearch Professional Group, Inc.

Hialeah, Florida, United States

Location

The Community Research of South Florida

Hialeah, Florida, United States

Location

Center for Gastrointestinal Disorders

Hollywood, Florida, United States

Location

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

Location

Gastroenterology and Hepatology Associates

Jacksonville, Florida, United States

Location

Jupiter Research Inc.

Jupiter, Florida, United States

Location

Center for Advanced Gastroenterology

Maitland, Florida, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, United States

Location

Research Institute of South Florida

Miami, Florida, United States

Location

Gastroenterology Group of Naples

Naples, Florida, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, United States

Location

Georgia Clinical Research

Snellville, Georgia, United States

Location

Elite Clinical Trials, Inc.

Blackfoot, Idaho, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Location

MidAtlantic Medical Research Centers, Philip J. Bean Medical Center

Hollywood, Maryland, United States

Location

Boston Clinical Trials

Boston, Massachusetts, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, United States

Location

Midwest Gastroenterology Partners

Lee's Summit, Missouri, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Location

ActivMed Practices and Research, Inc.

Newington, New Hampshire, United States

Location

HOSC, Inc.

Brooklyn, New York, United States

Location

North American Partners in Pain Management

Valley Stream, New York, United States

Location

Carolina Digestive Health Associates, PA

Davidson, North Carolina, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Location

Gastroenterology Research Consultants of Greater Cincinnati

Cincinnati, Ohio, United States

Location

Hometown Urgent Care and Occupational Health

Groveport, Ohio, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

Location

Mainline Gastroenterology Associates

Souderton, Pennsylvania, United States

Location

ClinSearch

Chattanooga, Tennessee, United States

Location

Memphis Gastroenterology Group, PC

Germantown, Tennessee, United States

Location

KRK Medical Research

Dallas, Texas, United States

Location

Research Across America

Dallas, Texas, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Location

Pioneer Research Solutions, Inc.

Sugar Land, Texas, United States

Location

Northwest Gastroenterology Associates

Bellevue, Washington, United States

Location

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Location

Huisartspraktijk Jaak Mortelmans

Ham, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Faculdade de Medicina do ABC

Sant André, São Paulo, Brazil

Location

Escola Paulista de Medicina, Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Location

John Buhler Research Center

Winnipeg, Manitoba, Canada

Location

Maritime Medical Research Center

Bathurst, New Brunswick, Canada

Location

Prime Health Clinical Research Organization

Toronto, Ontario, Canada

Location

Alpha Clinical Research LLC

Québec, Quebec, Canada

Location

Rhodin Recherche Clinique

DrummondvilleQC, Canada

Location

Derma Plus s.r.o.

České Budějovice, Czechia

Location

Gastroenterologie, s. r. o.

Hradec Králové, Czechia

Location

Nemocnice Valasske Mezirici a.s., Gastroenterologicka ambulance

Valašské Meziříčí, Czechia

Location

Klinikum der Universität München-Großhadern

München, Bavaria, Germany

Location

Israelitisches Krankenhaus Hamburg

Hamburg, Hamburg, Germany

Location

Synexus Clinical Research GmbH

Frankfurt am Main, Hesse, Germany

Location

Elbe Klinikum Stade - Buxtehude GmbH

Stade, Lower Saxony, Germany

Location

Synexus Clinical Research GmbH

Bochum, North Rhine-Westphalia, Germany

Location

Synexus Clinical Research GmbH

Leipzig, Saxony, Germany

Location

Emovis GmbH

Berlin, State of Berlin, Germany

Location

Synexus Clinical Research GmbH

Berlin, State of Berlin, Germany

Location

Universitätsklinik Charité, Campus Mitte

Berlin, State of Berlin, Germany

Location

Soroka University Medical Center

Beersheba, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Hadassah Medical Organization, Ein Kerem

Jerusalem, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Assaf Harofeh Medical Centre

Ẕerifin, Israel

Location

Szpital Wojewódzki w Opolu

Opole, Opole Voivodeship, Poland

Location

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

Częstochowa, Silesian Voivodeship, Poland

Location

Neuro-Care NZOZ

Katowice, Silesian Voivodeship, Poland

Location

Pomorski Uniwersytet Medyczny

Szczecin, West Pomeranian Voivodeship, Poland

Location

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

Lódz, Łódź Voivodeship, Poland

Location

Global Clinical Trials

Port Elizabeth, Eastern Cape, South Africa

Location

Boanerges Clinical Research

Bloemfontein, Free State, South Africa

Location

Synexus Clinical Research SA

Pretoria, Gauteng, South Africa

Location

Parklands Medical Centre

Durban, KwaZulu-Natal, South Africa

Location

Boland Ethical Research Group

Worcester, Western Cape, South Africa

Location

The Memory Centre

Johannesburg, South Africa

Location

Langeberg Clinical Trials

Kraaifontein, South Africa

Location

Newtown Clinical Research Centre

Newtown, South Africa

Location

Synexus Midlands Clinical Research Centre

Birmingham, England, United Kingdom

Location

County Durham and Darlington NHS Foundation Trust

Durham, England, United Kingdom

Location

Synexus Manchester Clinical Research Centre

Manchester, England, United Kingdom

Location

Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Location

Synexus Wales Clinical Research Centre

Cardiff, Wales, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

elobixibat

Limitations and Caveats

Due to the early termination of the study, outcomes were presented only for descriptive purposes.

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 20, 2015
• Results First Posted: October 20, 2015

Record last verified: 2015-09

Locations

BE (3); CZ (3); IL (6); DE (9); US (46); BR (3); CA (5); PL (5); ZA (8); GB (6)