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Chronic Idiopathic ConstipationPhase 3NCT01895543

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

A Phase 3 study testing Elobixibat 10 mg in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 62 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC) 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
62 sitesin 10 countries
Study dates
Sep 2013to May 2015
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

  • Has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080.
  • The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments.
  • The patient agrees to refrain from making any new, major lifestyle changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.

Who cannot join

  • The patient has been withdrawn/discontinued from the 000079 or 000080 trials.
  • The patient is not willing to abide by the restrictions for intake of prohibited medication.
  • Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have a positive urine pregnancy test at Visit 1, or who do not agree to use one of the following methods of birth control from the day of signing the ICF until 30 days after the final dose of trial drug are excluded:
  • Transdermal patch
  • Established use of oral, injected or implanted hormonal methods of contraception
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Show all 10Show fewer
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
  • True sexual abstinence: when this is in line with the preferred and usual lifestyle of the patient.
  • The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason.

Trial locations and contacts

62 sites in 10 countries.

62 sites in 10 countries

United States53 sites

  • Anderson Gastroenterology Associates

    Anderson, South Carolina

  • Mount Vernon Clinical Research

    Atlanta, Georgia

  • Heartland Research Associates, LLC

    Augusta, Kansas

  • Northwest Gastroenterology Associates

    Bellevue, Washington

  • Boston Clinical Trials

    Boston, Massachusetts

  • Zasa Clinical Research

    Boynton Beach, Florida

  • Meridien Research

    Bradenton, Florida

  • Pulmonary Associates of Brandon

    Brandon, Florida

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts

  • Skyline Research, LLC

    Cerritos, California

  • ClinSearch

    Chattanooga, Tennessee

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia

  • TriHealth, Inc.

    Cincinnati, Ohio

  • Carolina Digestive Health Associates, PA

    Concord, North Carolina

  • KRK Medical Research

    Dallas, Texas

  • Evanston Hospital

    Evanston, Illinois

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee

  • 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

  • Medsearch Professional Group, Inc.

    Hialeah, Florida

  • The Community Research of South Florida

    Hialeah, Florida

  • Peters Medical Research, LLC

    High Point, North Carolina

  • Center for Gastrointestinal Disorders

    Hollywood, Florida

  • Pioneer Research Solutions, Inc.

    Houston, Texas

  • Nature Coast Clinical Research, LLC

    Inverness, Florida

  • HCCA Clinical Research Solutions

    Jackson, Tennessee

  • Health Awareness, Inc.

    Jupiter, Florida

  • Jupiter Research Inc.

    Jupiter, Florida

  • Advanced Biomedical Research of America

    Las Vegas, Nevada

  • Family Medical Associates

    Levittown, Pennsylvania

  • Preferred Research Partners

    Little Rock, Arkansas

  • West Gastroenterology Associates

    Los Angeles, California

  • Sunstone Medical Research, LLC

    Medford, Oregon

  • Advanced Pharma CR, LLC

    Miami, Florida

  • Research Institute of South Florida

    Miami, Florida

  • ActivMed Practices and Research, Inc.

    Newington, New Hampshire

  • Arkansas Gastroenterology

    North Little Rock, Arkansas

  • Clinical Research Associates, LLC

    Oklahoma City, Oklahoma

  • Quality Clinical Research, Inc.

    Omaha, Nebraska

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois

  • Sacramento Research Medical Group

    Sacramento, California

  • Louisiana Research Center, LLC

    Shreveport, Louisiana

  • Georgia Clinical Research

    Snellville, Georgia

  • Stamford Therapeutics Consortium

    Stamford, Connecticut

  • Pioneer Research Solutions, Inc.

    Sugar Land, Texas

  • Genova Clinical Research, Inc.

    Tucson, Arizona

  • Palm Beach Research Center

    West Palm Beach, Florida

  • Heartland Research Associates, LLC

    Wichita, Kansas

Other trials in United States

Belgium1 site

  • Cliniques Universitaires Saint Luc (there may be other sites in this country)

    Brussels

Other trials in Belgium

Canada1 site

  • Prime Health Clinical Research Organization (there may be other sites in this country)

    Toronto, Ontario

Other trials in Canada

Czechia1 site

  • Gastroenterologie, s. r. o. (there may be other sites in this country)

    Hradec Králové

Other trials in Czechia

Hungary1 site

  • Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)

    Budapest

Other trials in Hungary

Poland1 site

  • SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)

    Lódz, Łódź Voivodeship

Other trials in Poland

Slovakia1 site

  • KM Management sro (there may be other sites in this country)

    Nitra

Other trials in Slovakia

South Africa1 site

  • Louise Lelpoldt Medical Centre (there may be other sites in this country)

    Bellville, Western Cape

Other trials in South Africa

Sweden1 site

  • Uppsala Akademiska Sjukhus (there may be other sites in this country)

    Uppsala

Other trials in Sweden

United Kingdom1 site

  • Synexus Merseyside Clinical Research Centre (there may be other sites in this country)

    Liverpool, England

Other trials in United Kingdom

About this study

Official title: A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

Read the detailed description

This was a Phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week Treatment Period in patients with CIC. A dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment.

The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).

Being tested
Elobixibat 10 mg

What participants receive

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

  • Elobixibat 10 mgDrug

    10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

Study groups in NCT01895543
Study groupRoleWhat they receive
EBX10ExperimentalElobixibat 10 mg
Receives: Drug: Elobixibat 10 mg

What is being measured

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

  1. Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.

    Measured: For the overall 52-week Treatment Period

  2. Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables

    Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry

    Measured: For the overall 52-week Treatment Period

  3. Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)

    A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.

    Measured: For the overall 52-week Treatment Period

  4. Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs

    Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.

    Measured: For the overall 52-week Treatment Period

  5. Number of Patients Using Concomitant Medications

    The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.

    Measured: For the overall 52-week Treatment Period

Secondary outcomes (6)

  1. Use of Concomitant Over-the-counter (OTC) Laxatives

    The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).

    Measured: For the overall 52-week Treatment Period

  2. Change From Baseline in Global Evaluation of Constipation Severity

    The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).

    Measured: At Week 12, 24, 36, and 52

  3. Change From Baseline in Global Evaluation of Treatment Effectiveness

    The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).

    Measured: At Week 12, 24, 36, and 52

  4. Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score

    PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 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 QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: 'Worries and Concerns', 'Physical Discomfort', 'Psychosocial Discomfort', and 'Dissatisfaction'.

    Measured: At Week 12, 24, 36 and 52

  5. Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores

    EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.

    Measured: At Week 12, 24, 36 and 52

  6. Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score

    The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate "how his/her health is TODAY" and mention the same number in a box provided.

    Measured: At Week 12, 24, 36 and 52

Timeline

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

  1. First posted10 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01895543
Sponsor's protocol ID
000081
Other IDs
2012-005601-46
Status last verified
Apr 2016
First submitted
28 Jun 2013
Last updated
9 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elobixibat 10 mg in people with Chronic Idiopathic Constipation, run by Ferring Pharmaceuticals at 62 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Belgium, Canada, Czechia, Hungary 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. 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 9 May 2016). 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?

Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: For the overall 52-week Treatment Period). The study lists 5 primary outcomes in all. 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 NCT01895543.

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 9 May 2016.

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