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Chronic Idiopathic ConstipationPhase 3NCT01833065

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

A Phase 3 study testing Elobixibat 10 mg/day and Elobixibat 5 mg/day in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 97 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Idiopathic Constipation
What is being tested?
Elobixibat 10 mg/day and Elobixibat 5 mg/day
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
97 sitesin 12 countries
Study dates
Apr 2013to Apr 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

97 sites in 12 countries.

97 sites in 12 countries

United States45 sites

  • Anderson Gastroenterology Associates

    Anderson, South Carolina

  • Mount Vernon Clinical Research

    Atlanta, Georgia

  • Heartland Research Associates, LLC

    Augusta, Kansas

  • Birmingham Gastroenterology Associates, PC

    Birmingham, Alabama

  • Zasa Clinical Research

    Boynton Beach, Florida

  • Meridien Research

    Bradenton, Florida

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts

  • Carolina Digestive Health Associates, PA

    Charlotte, North Carolina

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia

  • Southeast Regional Research Group

    Columbus, Georgia

  • Hometown Urgent Care and Occupational Health

    Columbus, Ohio

  • Carolina Digestive Health Associates, PA

    Concord, North Carolina

  • Sanitas Research

    Coral Gables, Florida

  • Hometown Urgent Care and Occupational Health

    Dayton, Ohio

  • Lake Internal Medicine Associates

    Eustis, Florida

  • Premier Healthcare Research, LLC

    Evanston, Illinois

  • Long Island Gastrointestinal Research Group

    Great Neck, New York

  • PharmQuest, LLC

    Greensboro, North Carolina

  • Associates in Gastroenterology, LLC

    Hermitage, Tennessee

  • Health Care Family Rehab Corp.

    Hialeah, Florida

  • Peters Medical Research, LLC

    High Point, North Carolina

  • HCCA Clinical Research Solutions

    Jackson, Tennessee

  • Southeast Clinical Research, LLC

    Jacksonville, Florida

  • Health Awareness, Inc.

    Jupiter, Florida

  • Research Across America

    Katy, Texas

  • New Phase Research and Development, LLC

    Knoxville, Tennessee

  • Family Medical Associates

    Levittown, Pennsylvania

  • Preferred Research Partners

    Little Rock, Arkansas

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

    Los Angeles, California

  • West Gastroenterology Associates

    Los Angeles, California

  • Sunstone Medical Research, LLC

    Medford, Oregon

  • Arkansas Gastroenterology

    North Little Rock, Arkansas

  • Clinical Research Associates, LLC

    Oklahoma City, Oklahoma

  • Quality Clinical Research, Inc.

    Omaha, Nebraska

  • Wake Research Associates, LLC

    Raleigh, North Carolina

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois

  • Sacramento Research Medical Group

    Sacramento, California

  • Precision Research Institute, LLC

    San Diego, California

  • Louisiana Research Center, LLC

    Shreveport, Louisiana

  • Palmetto Clinical Research

    Summerville, South Carolina

  • Genova Clinical Research, Inc.

    Tucson, Arizona

  • Family Practice Center of Wadsworth

    Wadsworth, Ohio

  • Heartland Research Associates, LLC

    Wichita, Kansas

  • Professional Research Network of Kansas, LLC

    Witchita, Kansas

Other trials in United States

Hungary10 sites

  • Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

    Budapest

  • Pannónia Magánorvosi Centrum Kft.

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft

    Debrecen

  • Pándy Kálmán Megyei Kórház

    Gyula, Bekes County

  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc

  • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház

    Miskolc

  • Clinfan Szolgáltató Kft

    Szekszárd

  • CRU Hungary Kft.

    Szikszó

  • Jávorszky Ödön Kórház

    Vác

Other trials in Hungary

Poland7 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, Lesser Poland Voivodeship

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

    Lódz, Łódź Voivodeship

  • Medicor Centrum Medyczne Tadeusz Mazurek

    Rzeszów, Podkarpackie Voivodeship

  • Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon

    Torun, Kuyavian-Pomeranian Voivodeship

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

    Warsaw, Masovian Voivodeship

  • Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

    Warsaw, Masovian Voivodeship

Other trials in Poland

South Africa6 sites

  • Louis Leipoldt Medi-Clinic Medical Centre

    Bellville, Western Cape

  • JOSHA Research

    Bloemfontein, Free State

  • Dr. Zubar Fazel Vawda

    Durban, KwaZulu-Natal

  • Mzansi Ethical Research Centre

    Middelburg, Mpumalanga

  • Be Part Yoluntu Centre

    Paarl, Western Cape

  • Synexus Clinical Research SA

    Pretoria, Gauteng

Other trials in South Africa

Canada5 sites

  • Medical Arts Health Research Group

    Penticton, British Columbia

  • Pro-Recherche Polyclinique des Ponts

    Saint Romuald, Quebec

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario

  • Dr Anil K Gupta Medicine Professional Corp.

    Toronto, Ontario

  • Toronto Digestive Diseases Associates, Inc.

    Toronto, Ontario

Other trials in Canada

Slovakia5 sites

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

    Bratislava

  • PIGEAS s.r.o.

    Martin

  • KM Management sro

    Nitra

  • Gastro I.s.r.o.

    Prešov, Presov

  • GEA s.r.o Gastroenterologicka ambulancia

    Trnava

Other trials in Slovakia

Mexico4 sites

  • Hospital Centro Internacional de Medicina Chihuahua

    Chihuahua City, Chihuahua

  • Centro de Investigación Médico Biológica y Terapia Avanzada SC

    Guadalajara, Jalisco

  • Medical Care and Research

    Mérida, Yucatán

  • Accelerium Clinical Research

    Monterrey, Nuevo León

Other trials in Mexico

United Kingdom4 sites

  • Synexus Lancashire Clinical Research Centre

    Chorley, England

  • Synexus Scotland Clinical Research Centre

    Glasgow, Scotland

  • Synexus Merseyside Clinical Research Centre

    Liverpool, England

  • Synexus Thames Valley Clinical Research Centre

    Reading, England

Other trials in United Kingdom

Brazil3 sites

  • Fundacao IMEPEM - Universidade Federal de Juiz de Fora

    Juiz de Fora, Minas Gerais

  • Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda

    Rio de Janeiro, Rio de Janeiro

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo

Other trials in Brazil

Germany3 sites

  • Synexus Clinical Research GmbH

    Dresden, Saxony

  • Synexus Clinical Research GmbH

    Görlitz, Saxony

  • Synexus Clinical Research GmbH

    Magdeburg, Saxony-Anhalt

Other trials in Germany

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Karolinska University Hospital Huddinge

    Stockholm

  • Uppsala Akademiska Sjukhus

    Uppsala

Other trials in Sweden

Czechia2 sites

  • Gastroenterologicka a interni ambulance

    České Budějovice

  • Fakultní Nemocnice Ostrava

    Ostrava, Severomoravsky Kraj

Other trials in Czechia

About this study

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 12 Weeks Followed by a 4-week Withdrawal Period

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

Read the 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.

Being tested
Elobixibat 10 mg/day, Elobixibat 5 mg/day, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elobixibat 10 mg/dayDrug

    Also called A3309

    Elobixibat 10 mg/day

  • Elobixibat 5 mg/dayDrug

    Also called A3309

    Elobixibat 5 mg/day

  • PlaceboDrug

    Placebo

Study groups in NCT01833065
Study groupRoleWhat they receive
EBX 10ExperimentalElobixibat 10 mg/day
Receives: Drug: Elobixibat 10 mg/day
EBX 5ExperimentalElobixibat 5 mg/day
Receives: Drug: Elobixibat 5 mg/day
PLCBOPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the first 12 weeks

Secondary outcomes (7)

  1. Occurrence of CSBM Response

    This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').

    Measured: Within first 24 hours of treatment initiation

  2. Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)

    The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.

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

  3. Change From Baseline in Weekly Stool Consistency of SBMs

    The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.

    Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .

    For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

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

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

    This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.

    PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.

    Total PAC-QOL score was averaged from the individual item score.

    Measured: At Week 12

  5. Change From Baseline in Weekly Degree of Straining of SBMs

    The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).

    For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

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

  6. Change From Baseline in Weekly Abdominal Bloating Score

    The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

    For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

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

  7. Change From Baseline in Weekly Abdominal Discomfort Score

    The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).

    For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2014
  4. Study completionApr 2014

Why it stopped: Terminated due to a distribution issue with the trial medication

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01833065
Sponsor's protocol ID
000080
Other IDs
2012-005588-28
Status last verified
Sep 2015
First submitted
12 Apr 2013
Last updated
20 Oct 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elobixibat 10 mg/day and Elobixibat 5 mg/day in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 97 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Hungary, Poland, South Africa, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Complete Spontaneous Bowel Movement (CSBM) Response (time frame: During the first 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01833065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

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