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

NCT ID: NCT01833065

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

Brief Summary

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

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 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.

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/day

Intervention Type: DRUG

Elobixibat 10 mg/day

EBX 5

Elobixibat 5 mg/day

Group Type: EXPERIMENTAL

Elobixibat 5 mg/day

Intervention Type: DRUG

Elobixibat 5 mg/day

PLCBO

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Elobixibat 10 mg/day

Elobixibat 10 mg/day

Intervention Type: DRUG

Elobixibat 5 mg/day

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 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

• 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

Birmingham Gastroenterology Associates, PC

Birmingham, Alabama, United States

Genova Clinical Research, Inc.

Tucson, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

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

Los Angeles, California, United States

West Gastroenterology Associates

Los Angeles, California, United States

Sacramento Research Medical Group

Sacramento, California, United States

Precision Research Institute, LLC

San Diego, California, United States

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, United States

Zasa Clinical Research

Boynton Beach, Florida, United States

Meridien Research

Bradenton, Florida, United States

Sanitas Research

Coral Gables, Florida, United States

Lake Internal Medicine Associates

Eustis, Florida, United States

Health Care Family Rehab Corp.

Hialeah, Florida, United States

Southeast Clinical Research, LLC

Jacksonville, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Mount Vernon Clinical Research

Atlanta, Georgia, United States

Southeast Regional Research Group

Columbus, Georgia, United States

Premier Healthcare Research, LLC

Evanston, Illinois, United States

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, United States

Heartland Research Associates, LLC

Augusta, Kansas, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Professional Research Network of Kansas, LLC

Witchita, Kansas, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Long Island Gastrointestinal Research Group

Great Neck, New York, United States

Carolina Digestive Health Associates, PA

Charlotte, North Carolina, United States

Carolina Digestive Health Associates, PA

Concord, North Carolina, United States

PharmQuest, LLC

Greensboro, North Carolina, United States

Peters Medical Research, LLC

High Point, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Hometown Urgent Care and Occupational Health

Columbus, Ohio, United States

Hometown Urgent Care and Occupational Health

Dayton, Ohio, United States

Family Practice Center of Wadsworth

Wadsworth, Ohio, United States

Clinical Research Associates, LLC

Oklahoma City, Oklahoma, United States

Sunstone Medical Research, LLC

Medford, Oregon, United States

Family Medical Associates

Levittown, Pennsylvania, United States

Anderson Gastroenterology Associates

Anderson, South Carolina, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Associates in Gastroenterology, LLC

Hermitage, Tennessee, United States

HCCA Clinical Research Solutions

Jackson, Tennessee, United States

New Phase Research and Development, LLC

Knoxville, Tennessee, United States

Research Across America

Katy, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Fundacao IMEPEM - Universidade Federal de Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Medical Arts Health Research Group

Penticton, British Columbia, Canada

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Dr Anil K Gupta Medicine Professional Corp.

Toronto, Ontario, Canada

Toronto Digestive Diseases Associates, Inc.

Toronto, Ontario, Canada

Pro-Recherche Polyclinique des Ponts

Saint Romuald, Quebec, Canada

Fakultní Nemocnice Ostrava

Ostrava, Severomoravsky Kraj, Czechia

Gastroenterologicka a interni ambulance

České Budějovice, , Czechia

Synexus Clinical Research GmbH

Dresden, Saxony, Germany

Synexus Clinical Research GmbH

Görlitz, Saxony, Germany

Synexus Clinical Research GmbH

Magdeburg, Saxony-Anhalt, Germany

Pándy Kálmán Megyei Kórház

Gyula, Bekes County, Hungary

Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

Budapest, , Hungary

Pannónia Magánorvosi Centrum Kft.

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft

Debrecen, , Hungary

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, , Hungary

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház

Miskolc, , Hungary

Clinfan Szolgáltató Kft

Szekszárd, , Hungary

CRU Hungary Kft.

Szikszó, , Hungary

Jávorszky Ödön Kórház

Vác, , Hungary

Hospital Centro Internacional de Medicina Chihuahua

Chihuahua City, Chihuahua, Mexico

Centro de Investigación Médico Biológica y Terapia Avanzada SC

Guadalajara, Jalisco, Mexico

Accelerium Clinical Research

Monterrey, Nuevo León, Mexico

Medical Care and Research

Mérida, Yucatán, Mexico

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

Warsaw, Masovian Voivodeship, Poland

Medicor Centrum Medyczne Tadeusz Mazurek

Rzeszów, Podkarpackie Voivodeship, Poland

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

Lódz, Łódź Voivodeship, Poland

Gastro I.s.r.o.

Prešov, Presov, Slovakia

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

Bratislava, , Slovakia

PIGEAS s.r.o.

Martin, , Slovakia

KM Management sro

Nitra, , Slovakia

GEA s.r.o Gastroenterologicka ambulancia

Trnava, , Slovakia

JOSHA Research

Bloemfontein, Free State, South Africa

Synexus Clinical Research SA

Pretoria, Gauteng, South Africa

Dr. Zubar Fazel Vawda

Durban, KwaZulu-Natal, South Africa

Mzansi Ethical Research Centre

Middelburg, Mpumalanga, South Africa

Louis Leipoldt Medi-Clinic Medical Centre

Bellville, Western Cape, South Africa

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

Sahlgrenska University Hospital

Gothenburg, , Sweden

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Uppsala Akademiska Sjukhus

Uppsala, , Sweden

Synexus Lancashire Clinical Research Centre

Chorley, England, United Kingdom

Synexus Merseyside Clinical Research Centre

Liverpool, England, United Kingdom

Synexus Thames Valley Clinical Research Centre

Reading, England, United Kingdom

Synexus Scotland Clinical Research Centre

Glasgow, Scotland, United Kingdom

Countries

United States; Brazil; Canada; Czechia; Germany; Hungary; Mexico; Poland; Slovakia; South Africa; Sweden; United Kingdom

Other Identifiers

2012-005588-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000080

Identifier Type: -

Identifier Source: org_study_id