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Chronic Idiopathic ConstipationPhase 3NCT01827592

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

A Phase 3 study testing Elobixibat 10 mg and Elobixibat 5 mg in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 94 sites in 10 countries.

Terminated

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

Official record
Search all trials

Trial summary

Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks. 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 and Elobixibat 5 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
376 participants
Where
94 sitesin 10 countries
Study dates
Apr 2013to May 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 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
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 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

Trial locations and contacts

94 sites in 10 countries.

94 sites in 10 countries

United States46 sites

  • University of Michigan Health System

    Ann Arbor, Michigan

  • Northwest Gastroenterology Associates

    Bellevue, Washington

  • Alabama Clinical Therapeutics

    Birmingham, Alabama

  • Elite Clinical Trials, Inc.

    Blackfoot, Idaho

  • Boston Clinical Trials

    Boston, Massachusetts

  • Pulmonary Associates of Brandon

    Brandon, Florida

  • HOSC, Inc.

    Brooklyn, New York

  • Skyline Research LLC

    Cerritos, California

  • ClinSearch

    Chattanooga, Tennessee

  • GW Research, Inc.

    Chula Vista, California

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio

  • KRK Medical Research

    Dallas, Texas

  • Research Across America

    Dallas, Texas

  • Carolina Digestive Health Associates, PA

    Davidson, North Carolina

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina

  • G and L Research, LLC

    Foley, Alabama

  • Paradigm Clinical, Inc.

    Garden Grove, California

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee

  • Hometown Urgent Care and Occupational Health

    Groveport, Ohio

  • In Vivo Clinical Research, Inc.

    Hialeah, Florida

  • Medsearch Professional Group, Inc.

    Hialeah, Florida

  • The Community Research of South Florida

    Hialeah, Florida

  • Center for Gastrointestinal Disorders

    Hollywood, Florida

  • MidAtlantic Medical Research Centers, Philip J. Bean Medical Center

    Hollywood, Maryland

  • Pioneer Research Solutions, Inc.

    Houston, Texas

  • Nature Coast Clinical Research, LLC

    Inverness, Florida

  • Gastroenterology and Hepatology Associates

    Jacksonville, Florida

  • Jupiter Research Inc.

    Jupiter, Florida

  • Advanced Biomedical Research of America

    Las Vegas, Nevada

  • Midwest Gastroenterology Partners

    Lee's Summit, Missouri

  • Center for Advanced Gastroenterology

    Maitland, Florida

  • Advanced Pharma CR, LLC

    Miami, Florida

  • Research Institute of South Florida

    Miami, Florida

  • Gastroenterology Group of Naples

    Naples, Florida

  • ActivMed Practices and Research, Inc.

    Newington, New Hampshire

  • Providence Clinical Research

    North Hollywood, California

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania

  • Georgia Clinical Research

    Snellville, Georgia

  • Mainline Gastroenterology Associates

    Souderton, Pennsylvania

  • Stamford Therapeutics Consortium

    Stamford, Connecticut

  • Pioneer Research Solutions, Inc.

    Sugar Land, Texas

  • Adobe Gastroenterology Research, LLC

    Tucson, Arizona

  • North American Partners in Pain Management

    Valley Stream, New York

  • Palm Beach Research Center

    West Palm Beach, Florida

Other trials in United States

Germany9 sites

  • Emovis GmbH

    Berlin, State of Berlin

  • Synexus Clinical Research GmbH

    Berlin, State of Berlin

  • Universitätsklinik Charité, Campus Mitte

    Berlin, State of Berlin

  • Synexus Clinical Research GmbH

    Bochum, North Rhine-Westphalia

  • Synexus Clinical Research GmbH

    Frankfurt am Main, Hesse

  • Israelitisches Krankenhaus Hamburg

    Hamburg, Free and Hanseatic City of Hamburg

  • Synexus Clinical Research GmbH

    Leipzig, Saxony

  • Klinikum der Universität München-Großhadern

    München, Bavaria

  • Elbe Klinikum Stade - Buxtehude GmbH

    Stade, Lower Saxony

Other trials in Germany

South Africa8 sites

  • Boanerges Clinical Research

    Bloemfontein, Free State

  • Parklands Medical Centre

    Durban, KwaZulu-Natal

  • The Memory Centre

    Johannesburg

  • Langeberg Clinical Trials

    Kraaifontein

  • Newtown Clinical Research Centre

    Newtown

  • Global Clinical Trials

    Port Elizabeth, Eastern Cape

  • Synexus Clinical Research SA

    Pretoria, Gauteng

  • Boland Ethical Research Group

    Worcester, Western Cape

Other trials in South Africa

Israel6 sites

  • Soroka University Medical Center

    Beersheba

  • Bnai Zion Medical Center

    Haifa

  • Hadassah Medical Organization, Ein Kerem

    Jerusalem

  • Kaplan Medical Center

    Rehovot

  • Sheba Medical Center

    Tel HaShomer

  • Assaf Harofeh Medical Centre

    Tsrifin

Other trials in Israel

United Kingdom6 sites

  • Synexus Midlands Clinical Research Centre

    Birmingham, England

  • Synexus Wales Clinical Research Centre

    Cardiff, Wales

  • Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School

    Dundee, Scotland

  • County Durham and Darlington NHS Foundation Trust

    Durham, England

  • Synexus Manchester Clinical Research Centre

    Manchester, England

  • Nottingham University Hospitals NHS Trust

    Nottingham

Other trials in United Kingdom

Canada5 sites

  • Maritime Medical Research Center

    Bathurst, New Brunswick

  • Rhodin Recherche Clinique

    DrummondvilleQC

  • Alpha Clinical Research LLC

    Québec, Quebec

  • Prime Health Clinical Research Organization

    Toronto, Ontario

  • John Buhler Research Center

    Winnipeg, Manitoba

Other trials in Canada

Poland5 sites

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

    Częstochowa, Silesian Voivodeship

  • Neuro-Care NZOZ

    Katowice, Silesian Voivodeship

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

    Lódz, Łódź Voivodeship

  • Szpital Wojewódzki w Opolu

    Opole, Opole Voivodeship

  • Pomorski Uniwersytet Medyczny

    Szczecin, West Pomeranian Voivodeship

Other trials in Poland

Belgium3 sites

  • Cliniques Universitaires Saint Luc

    Brussels, Brussels Capital

  • Huisartspraktijk Jaak Mortelmans

    Ham

  • Universitair Ziekenhuis Leuven

    Leuven

Other trials in Belgium

Brazil3 sites

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Faculdade de Medicina do ABC

    Sant André, São Paulo

  • Escola Paulista de Medicina, Universidade Federal de São Paulo

    São Paulo, São Paulo

Other trials in Brazil

Czechia3 sites

  • Derma Plus s.r.o.

    České Budějovice

  • Gastroenterologie, s. r. o.

    Hradec Králové

  • Nemocnice Valasske Mezirici a.s., Gastroenterologicka ambulance

    Valašské Meziříčí

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 26 Weeks

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

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 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.

Being tested
Elobixibat 10 mg, Elobixibat 5 mg, Placebo

What participants receive

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

  • Elobixibat 10 mgDrug

    Also called A3309

    Elobixibat 10 mg/day

  • Elobixibat 5 mgDrug

    Also called A3309

    Elobixibat 5 mg/day

  • PlaceboDrug

    Placebo

Study groups in NCT01827592
Study groupRoleWhat they receive
EBX 10ExperimentalElobixibat 10 mg/day
Receives: Drug: Elobixibat 10 mg
EBX 5ExperimentalElobixibat 5 mg/day
Receives: Drug: Elobixibat 5 mg
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 the first 24 hours of treatment initiation

  2. Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (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 of 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 12 weeks

  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 bloating 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 posted9 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2014
  4. Study completionMay 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
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827592
Sponsor's protocol ID
000079
Other IDs
2012-005587-94
Status last verified
Sep 2015
First submitted
5 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 and Elobixibat 5 mg in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 94 sites in 10 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 94 sites in United States, Germany, South Africa, Israel, United Kingdom and 5 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 NCT01827592.

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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