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Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elobixibat 10 mg
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The patient has been withdrawn/discontinued from the 000079 or 000080 trials.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:

    1. Transdermal patch
    2. Established use of oral, injected or implanted hormonal methods of contraception
    3. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    4. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    5. Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
    6. 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.

Sites / Locations

  • Genova Clinical Research, Inc.
  • Preferred Research Partners
  • Arkansas Gastroenterology
  • Skyline Research, LLC
  • West Gastroenterology Associates
  • Sacramento Research Medical Group
  • Stamford Therapeutics Consortium
  • Zasa Clinical Research
  • Meridien Research
  • Pulmonary Associates of Brandon
  • Health Care Family Rehab Corp.
  • Medsearch Professional Group, Inc.
  • The Community Research of South Florida
  • Center for Gastrointestinal Disorders
  • Nature Coast Clinical Research, LLC
  • Health Awareness, Inc.
  • Jupiter Research Inc.
  • Advanced Pharma CR, LLC
  • Research Institute of South Florida
  • Palm Beach Research Center
  • Mount Vernon Clinical Research
  • Georgia Clinical Research
  • Evanston Hospital
  • Rockford Gastroenterology Associates, Ltd.
  • MediSphere Medical Research Center, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Louisiana Research Center, LLC
  • Boston Clinical Trials
  • Beacon Clinical Research, LLC
  • Quality Clinical Research, Inc.
  • Advanced Biomedical Research of America
  • ActivMed Practices and Research, Inc.
  • Long Island Gastrointestinal Research Group
  • Carolina Digestive Health Associates, PA
  • Cumberland Research Associates, LLC
  • PharmQuest, LLC
  • Peters Medical Research, LLC
  • TriHealth, Inc.
  • Clinical Research Associates, LLC
  • Sunstone Medical Research, LLC
  • Family Medical Associates
  • Clinical Trials Research Services, LLC
  • Anderson Gastroenterology Associates
  • ClinSearch
  • Memphis Gastroenterology Group, PC
  • Associates in Gastroenterology, LLC
  • HCCA Clinical Research Solutions
  • KRK Medical Research
  • Pioneer Research Solutions, Inc.
  • Pioneer Research Solutions, Inc.
  • Gastroenterology Associates of Tidewater
  • Northwest Gastroenterology Associates
  • Cliniques Universitaires Saint Luc (there may be other sites in this country)
  • Prime Health Clinical Research Organization (there may be other sites in this country)
  • Gastroenterologie, s. r. o. (there may be other sites in this country)
  • Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)
  • SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)
  • KM Management sro (there may be other sites in this country)
  • Louise Lelpoldt Medical Centre (there may be other sites in this country)
  • Uppsala Akademiska Sjukhus (there may be other sites in this country)
  • Synexus Merseyside Clinical Research Centre (there may be other sites in this country)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBX10

Arm Description

Elobixibat 10 mg

Outcomes

Primary Outcome Measures

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.
Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables
Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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'.
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.
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.

Full Information

First Posted
June 28, 2013
Last Updated
April 29, 2016
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01895543
Brief Title
Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBX10
Arm Type
Experimental
Arm Description
Elobixibat 10 mg
Intervention Type
Drug
Intervention Name(s)
Elobixibat 10 mg
Intervention Description
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
For the overall 52-week Treatment Period
Title
Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables
Description
Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry
Time Frame
For the overall 52-week Treatment Period
Title
Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)
Description
A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.
Time Frame
For the overall 52-week Treatment Period
Title
Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs
Description
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.
Time Frame
For the overall 52-week Treatment Period
Title
Number of Patients Using Concomitant Medications
Description
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.
Time Frame
For the overall 52-week Treatment Period
Secondary Outcome Measure Information:
Title
Use of Concomitant Over-the-counter (OTC) Laxatives
Description
The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).
Time Frame
For the overall 52-week Treatment Period
Title
Change From Baseline in Global Evaluation of Constipation Severity
Description
The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).
Time Frame
At Week 12, 24, 36, and 52
Title
Change From Baseline in Global Evaluation of Treatment Effectiveness
Description
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).
Time Frame
At Week 12, 24, 36, and 52
Title
Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score
Description
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'.
Time Frame
At Week 12, 24, 36 and 52
Title
Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores
Description
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.
Time Frame
At Week 12, 24, 36 and 52
Title
Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score
Description
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.
Time Frame
At Week 12, 24, 36 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Skyline Research, LLC
City
Cerritos
State/Province
California
Country
United States
Facility Name
West Gastroenterology Associates
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Sacramento Research Medical Group
City
Sacramento
State/Province
California
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
Zasa Clinical Research
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Pulmonary Associates of Brandon
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Health Care Family Rehab Corp.
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Medsearch Professional Group, Inc.
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
The Community Research of South Florida
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Center for Gastrointestinal Disorders
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Nature Coast Clinical Research, LLC
City
Inverness
State/Province
Florida
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Jupiter Research Inc.
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Institute of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Georgia Clinical Research
City
Snellville
State/Province
Georgia
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Rockford Gastroenterology Associates, Ltd.
City
Rockford
State/Province
Illinois
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
ActivMed Practices and Research, Inc.
City
Newington
State/Province
New Hampshire
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Carolina Digestive Health Associates, PA
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
PharmQuest, LLC
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Peters Medical Research, LLC
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
TriHealth, Inc.
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Clinical Research Associates, LLC
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Family Medical Associates
City
Levittown
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburg
State/Province
Pennsylvania
Country
United States
Facility Name
Anderson Gastroenterology Associates
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Memphis Gastroenterology Group, PC
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Associates in Gastroenterology, LLC
City
Hermitage
State/Province
Tennessee
Country
United States
Facility Name
HCCA Clinical Research Solutions
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Cliniques Universitaires Saint Luc (there may be other sites in this country)
City
Brussels
Country
Belgium
Facility Name
Prime Health Clinical Research Organization (there may be other sites in this country)
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Gastroenterologie, s. r. o. (there may be other sites in this country)
City
Hradec Králové
Country
Czech Republic
Facility Name
Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)
City
Budapest
Country
Hungary
Facility Name
SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)
City
Lódz
State/Province
Lodzkie
Country
Poland
Facility Name
KM Management sro (there may be other sites in this country)
City
Nitra
Country
Slovakia
Facility Name
Louise Lelpoldt Medical Centre (there may be other sites in this country)
City
Bellville
State/Province
Western Cape
Country
South Africa
Facility Name
Uppsala Akademiska Sjukhus (there may be other sites in this country)
City
Uppsala
Country
Sweden
Facility Name
Synexus Merseyside Clinical Research Centre (there may be other sites in this country)
City
Liverpool
State/Province
England
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

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