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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005601-46 | EudraCT Number |
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Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBX10 | Experimental | Elobixibat 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elobixibat 10 mg | Drug | 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For the overall 52-week Treatment Period |
| Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables | Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry | For the overall 52-week Treatment Period |
| 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. | For the overall 52-week Treatment Period |
| 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. | For the overall 52-week Treatment Period |
| 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. | For the overall 52-week Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | For the overall 52-week Treatment Period |
| Change From Baseline in Global Evaluation of Constipation Severity |
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Inclusion Criteria:
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:
The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genova Clinical Research, Inc. | Tucson | Arizona | United States | |||
| Preferred Research Partners |
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The trial enrolled patients from two lead-in, double-blind efficacy trials (000079 and 000080).
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| ID | Title | Description |
|---|---|---|
| FG000 | EBX10 | Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The constipation severity score was measured on a 5-point scale (1: none to 5: very severe). |
| At Week 12, 24, 36, and 52 |
| 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). | At Week 12, 24, 36, and 52 |
| 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'. | At Week 12, 24, 36 and 52 |
| 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. | At Week 12, 24, 36 and 52 |
| 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. | At Week 12, 24, 36 and 52 |
| Little Rock |
| Arkansas |
| United States |
| Arkansas Gastroenterology | North Little Rock | Arkansas | United States |
| Skyline Research, LLC | Cerritos | California | United States |
| West Gastroenterology Associates | Los Angeles | California | United States |
| Sacramento Research Medical Group | Sacramento | California | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | United States |
| Zasa Clinical Research | Boynton Beach | Florida | United States |
| Meridien Research | Bradenton | Florida | United States |
| Pulmonary Associates of Brandon | Brandon | Florida | United States |
| Health Care Family Rehab Corp. | Hialeah | Florida | United States |
| Medsearch Professional Group, Inc. | Hialeah | Florida | United States |
| The Community Research of South Florida | Hialeah | Florida | United States |
| Center for Gastrointestinal Disorders | Hollywood | Florida | United States |
| Nature Coast Clinical Research, LLC | Inverness | Florida | United States |
| Health Awareness, Inc. | Jupiter | Florida | United States |
| Jupiter Research Inc. | Jupiter | Florida | United States |
| Advanced Pharma CR, LLC | Miami | Florida | United States |
| Research Institute of South Florida | Miami | Florida | United States |
| Palm Beach Research Center | West Palm Beach | Florida | United States |
| Mount Vernon Clinical Research | Atlanta | Georgia | United States |
| Georgia Clinical Research | Snellville | Georgia | United States |
| Evanston Hospital | Evanston | Illinois | United States |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | United States |
| Heartland Research Associates, LLC | Augusta | Kansas | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | United States |
| Boston Clinical Trials | Boston | Massachusetts | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | United States |
| Advanced Biomedical Research of America | Las Vegas | Nevada | United States |
| ActivMed Practices and Research, Inc. | Newington | New Hampshire | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | United States |
| Carolina Digestive Health Associates, PA | Concord | North Carolina | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States |
| PharmQuest, LLC | Greensboro | North Carolina | United States |
| Peters Medical Research, LLC | High Point | North Carolina | United States |
| TriHealth, Inc. | Cincinnati | 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 |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | United States |
| Anderson Gastroenterology Associates | Anderson | South Carolina | United States |
| ClinSearch | Chattanooga | Tennessee | United States |
| Memphis Gastroenterology Group, PC | Germantown | Tennessee | United States |
| Associates in Gastroenterology, LLC | Hermitage | Tennessee | United States |
| HCCA Clinical Research Solutions | Jackson | Tennessee | United States |
| KRK Medical Research | Dallas | Texas | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | United States |
| Pioneer Research Solutions, Inc. | Sugar Land | Texas | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | United States |
| Northwest Gastroenterology Associates | Bellevue | Washington | United States |
| Cliniques Universitaires Saint Luc (there may be other sites in this country) | Brussels | Belgium |
| Prime Health Clinical Research Organization (there may be other sites in this country) | Toronto | Ontario | Canada |
| Gastroenterologie, s. r. o. (there may be other sites in this country) | Hradec Králové | Czechia |
| Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country) | Budapest | Hungary |
| SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country) | Lódz | Łódź Voivodeship | Poland |
| KM Management sro (there may be other sites in this country) | Nitra | Slovakia |
| Louise Lelpoldt Medical Centre (there may be other sites in this country) | Bellville | Western Cape | South Africa |
| Uppsala Akademiska Sjukhus (there may be other sites in this country) | Uppsala | Sweden |
| Synexus Merseyside Clinical Research Centre (there may be other sites in this country) | Liverpool | England | United Kingdom |
| Safety Analysis Set |
|
| Per Protocol Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EBX10 | Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Height | Mean | Standard Deviation | Meters (m) |
| |||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilogram (Kg) |
| |||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables | Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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). | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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). | Safety Analysis Set | Posted | Mean | Standard Deviation | Unit on a scale | At Week 12, 24, 36, and 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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). | Safety Analysis Set | Posted | Mean | Standard Deviation | Unit on a scale | At Week 12, 24, 36, and 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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'. | Safety Analysis Set | Posted | Mean | Standard Deviation | Unit on a scale | At Week 12, 24, 36 and 52 |
|
| |||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Analysis Set | Posted | Number | Patients | For the overall 52-week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set | Posted | Mean | Standard Deviation | Unit on a scale | At Week 12, 24, 36 and 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Analysis Set | Posted | Mean | Standard Deviation | Unit on a scale | At Week 12, 24, 36 and 52 |
|
|
For the overall 52-week Treatment Period and the 2-week Follow-up Period
The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. Visit 6 - the end of the follow-up period) in the AEs Log . Information on AEs was collected at each trial visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EBX 10 | Elobixibat 10 mg Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily. | 14 | 409 | 77 | 409 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Emotional distress | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| C581303 | elobixibat |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Gamma Glutamyl Transferase (Units/Litre): >3*ULN |
| |||||
| Triglycerides : >3.39 millimoles/Litre |
| |||||
| LDL Cholesterol : >4.1 millimoles/Litre |
| |||||
| Glucose : <2.2 (F) and <2.8 (M) millimoles/Litre |
| |||||
| Activated Partial Thromboplastin Time : >70 second |
| |||||
| Prothrombin Time : >25 seconds |
| |||||
| Sodium : >155 millimoles/Litre |
| |||||
| Chloride : <90 millimoles/Litre |
| |||||
| Alanine Aminotransferase : >3*ULN |
| |||||
| Erythrocytes (10^12/L) : <3.1 |
| |||||
| Potassium : >6.5 millimoles/Litre |
| |||||
| Glucose : >22.2 millimoles/Litre |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Contact laxatives |
| |||||
| Osmotically acting laxatives |
| |||||
| Softeners, Emollients |
| |||||
| Bulk Producers |
| |||||
| Enemas |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| At Week 12 |
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| At Week 24 |
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| At Week 36 |
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| At Week 52 |
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