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

NCT01833065 | Terminated Phase 3 Results

• 2 other identifiers: 0000802012-005588-28
• Study Type: interventional
• Target: 314
• Locations: 12 countries
• Sites: 97

Brief Summary

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

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 first 24 hours of treatment initiation

• Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (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 Week 12

• 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/day

EBX 5

EXPERIMENTAL

Elobixibat 5 mg/day

Drug: Elobixibat 5 mg/day

PLCBO

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Elobixibat 10 mg/day DRUG

Elobixibat 10 mg/day

Also known as: A3309

EBX 10

Elobixibat 5 mg/day 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 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (97)

Birmingham Gastroenterology Associates, PC

Birmingham, Alabama, United States

Location

Genova Clinical Research, Inc.

Tucson, Arizona, United States

Location

Preferred Research Partners

Little Rock, Arkansas, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Location

David Geffen School of Medicine at University of California, Los Angeles

Los Angeles, California, United States

Location

West Gastroenterology Associates

Los Angeles, California, United States

Location

Sacramento Research Medical Group

Sacramento, California, United States

Location

Precision Research Institute, LLC

San Diego, California, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, United States

Location

Zasa Clinical Research

Boynton Beach, Florida, United States

Location

Meridien Research

Bradenton, Florida, United States

Location

Sanitas Research

Coral Gables, Florida, United States

Location

Lake Internal Medicine Associates

Eustis, Florida, United States

Location

Health Care Family Rehab Corp.

Hialeah, Florida, United States

Location

Southeast Clinical Research, LLC

Jacksonville, Florida, United States

Location

Health Awareness, Inc.

Jupiter, Florida, United States

Location

Mount Vernon Clinical Research

Atlanta, Georgia, United States

Location

Southeast Regional Research Group

Columbus, Georgia, United States

Location

Premier Healthcare Research, LLC

Evanston, Illinois, United States

Location

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, United States

Location

Professional Research Network of Kansas, LLC

Witchita, Kansas, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, United States

Location

Carolina Digestive Health Associates, PA

Charlotte, North Carolina, United States

Location

Carolina Digestive Health Associates, PA

Concord, North Carolina, United States

Location

PharmQuest, LLC

Greensboro, North Carolina, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Location

Hometown Urgent Care and Occupational Health

Columbus, Ohio, United States

Location

Hometown Urgent Care and Occupational Health

Dayton, Ohio, United States

Location

Family Practice Center of Wadsworth

Wadsworth, Ohio, United States

Location

Clinical Research Associates, LLC

Oklahoma City, Oklahoma, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, United States

Location

Family Medical Associates

Levittown, Pennsylvania, United States

Location

Anderson Gastroenterology Associates

Anderson, South Carolina, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, United States

Location

Associates in Gastroenterology, LLC

Hermitage, Tennessee, United States

Location

HCCA Clinical Research Solutions

Jackson, Tennessee, United States

Location

New Phase Research and Development, LLC

Knoxville, Tennessee, United States

Location

Research Across America

Katy, Texas, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Location

Fundacao IMEPEM - Universidade Federal de Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Location

Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Medical Arts Health Research Group

Penticton, British Columbia, Canada

Location

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

Dr Anil K Gupta Medicine Professional Corp.

Toronto, Ontario, Canada

Location

Toronto Digestive Diseases Associates, Inc.

Toronto, Ontario, Canada

Location

Pro-Recherche Polyclinique des Ponts

Saint Romuald, Quebec, Canada

Location

Fakultní Nemocnice Ostrava

Ostrava, Severomoravsky Kraj, Czechia

Location

Gastroenterologicka a interni ambulance

České Budějovice, Czechia

Location

Synexus Clinical Research GmbH

Dresden, Saxony, Germany

Location

Synexus Clinical Research GmbH

Görlitz, Saxony, Germany

Location

Synexus Clinical Research GmbH

Magdeburg, Saxony-Anhalt, Germany

Location

Pándy Kálmán Megyei Kórház

Gyula, Bekes County, Hungary

Location

Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

Budapest, Hungary

Location

Pannónia Magánorvosi Centrum Kft.

Budapest, Hungary

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft

Debrecen, Hungary

Location

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, Hungary

Location

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház

Miskolc, Hungary

Location

Clinfan Szolgáltató Kft

Szekszárd, Hungary

Location

CRU Hungary Kft.

Szikszó, Hungary

Location

Jávorszky Ödön Kórház

Vác, Hungary

Location

Hospital Centro Internacional de Medicina Chihuahua

Chihuahua City, Chihuahua, Mexico

Location

Centro de Investigación Médico Biológica y Terapia Avanzada SC

Guadalajara, Jalisco, Mexico

Location

Accelerium Clinical Research

Monterrey, Nuevo León, Mexico

Location

Medical Care and Research

Mérida, Yucatán, Mexico

Location

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

Location

Medica Pro Familia Sp. z o.o. S.K.A.

Warsaw, Masovian Voivodeship, Poland

Location

Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

Warsaw, Masovian Voivodeship, Poland

Location

Medicor Centrum Medyczne Tadeusz Mazurek

Rzeszów, Podkarpackie Voivodeship, Poland

Location

SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lódz, Łódź Voivodeship, Poland

Location

Gastro I.s.r.o.

Prešov, Presov, Slovakia

Location

Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion

Bratislava, Slovakia

Location

PIGEAS s.r.o.

Martin, Slovakia

Location

KM Management sro

Nitra, Slovakia

Location

GEA s.r.o Gastroenterologicka ambulancia

Trnava, Slovakia

Location

JOSHA Research

Bloemfontein, Free State, South Africa

Location

Synexus Clinical Research SA

Pretoria, Gauteng, South Africa

Location

Dr. Zubar Fazel Vawda

Durban, KwaZulu-Natal, South Africa

Location

Mzansi Ethical Research Centre

Middelburg, Mpumalanga, South Africa

Location

Louis Leipoldt Medi-Clinic Medical Centre

Bellville, Western Cape, South Africa

Location

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Uppsala Akademiska Sjukhus

Uppsala, Sweden

Location

Synexus Lancashire Clinical Research Centre

Chorley, England, United Kingdom

Location

Synexus Merseyside Clinical Research Centre

Liverpool, England, United Kingdom

Location

Synexus Thames Valley Clinical Research Centre

Reading, England, United Kingdom

Location

Synexus Scotland Clinical Research Centre

Glasgow, Scotland, 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 12, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 20, 2015
• Results First Posted: October 20, 2015

Record last verified: 2015-09

Locations

DE (3); CZ (2); ME (4); BR (3); HU (10); ZA (6); US (45); SL (5); PL (7); CA (5); SE (3); GB (4)