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

Primary Purpose

Chronic Idiopathic Constipation

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elobixibat 10 mg/day
Elobixibat 5 mg/day
Placebo
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:

  • 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:

    1. Straining during at least 25% of defecations
    2. Lumpy or hard stools during at least 25% of defecations
    3. 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Birmingham Gastroenterology Associates, PC
  • Genova Clinical Research, Inc.
  • Preferred Research Partners
  • Arkansas Gastroenterology
  • David Geffen School of Medicine at University of California, Los Angeles
  • West Gastroenterology Associates
  • Sacramento Research Medical Group
  • Precision Research Institute, LLC
  • Gastroenterology Associates of Fairfield County
  • Zasa Clinical Research
  • Meridien Research
  • Sanitas Research
  • Lake Internal Medicine Associates
  • Health Care Family Rehab Corp.
  • Southeast Clinical Research, LLC
  • Health Awareness, Inc.
  • Mount Vernon Clinical Research
  • Southeast Regional Research Group
  • Premier Healthcare Research, LLC
  • Rockford Gastroenterology Associates, Ltd.
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Professional Research Network of Kansas, LLC
  • Louisiana Research Center, LLC
  • Beacon Clinical Research, LLC
  • Quality Clinical Research, Inc.
  • Long Island Gastrointestinal Research Group
  • Carolina Digestive Health Associates, PA
  • Carolina Digestive Health Associates, PA
  • PharmQuest, LLC
  • Peters Medical Research, LLC
  • Wake Research Associates, LLC
  • Hometown Urgent Care and Occupational Health
  • Hometown Urgent Care and Occupational Health
  • Family Practice Center of Wadsworth
  • Clinical Research Associates, LLC
  • Sunstone Medical Research, LLC
  • Family Medical Associates
  • Anderson Gastroenterology Associates
  • Palmetto Clinical Research
  • Associates in Gastroenterology, LLC
  • HCCA Clinical Research Solutions
  • New Phase Research and Development, LLC
  • Research Across America
  • Gastroenterology Associates of Tidewater
  • Fundacao IMEPEM - Universidade Federal de Juiz de Fora
  • Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda
  • Hospital Israelita Albert Einstein
  • Medical Arts Health Research Group
  • London Road Diagnostic Clinic and Medical Centre
  • Dr Anil K Gupta Medicine Professional Corp.
  • Toronto Digestive Diseases Associates, Inc.
  • Pro-Recherche Polyclinique des Ponts
  • Fakultní Nemocnice Ostrava
  • Gastroenterologicka a interni ambulance
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Pándy Kálmán Megyei Kórház
  • Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
  • Pannónia Magánorvosi Centrum Kft.
  • Semmelweis Egyetem
  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft
  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház
  • Clinfan Szolgáltató Kft
  • CRU Hungary Kft.
  • Jávorszky Ödön Kórház
  • Centro de Investigación Médico Biológica y Terapia Avanzada SC
  • Accelerium Clinical Research
  • Medical Care and Research
  • Hospital Centro Internacional de Medicina Chihuahua
  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon
  • SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Medica Pro Familia Sp. z o.o. S.K.A.
  • Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
  • Medicor Centrum Medyczne Tadeusz Mazurek
  • Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
  • PIGEAS s.r.o.
  • KM Management sro
  • Gastro I.s.r.o.
  • GEA s.r.o Gastroenterologicka ambulancia
  • JOSHA Research
  • Synexus Clinical Research SA
  • Dr. Zubar Fazel Vawda
  • Mzansi Ethical Research Centre
  • Louis Leipoldt Medi-Clinic Medical Centre
  • Be Part Yoluntu Centre
  • Sahlgrenska University Hospital
  • Karolinska University Hospital Huddinge
  • Uppsala Akademiska Sjukhus
  • Synexus Lancashire Clinical Research Centre
  • Synexus Merseyside Clinical Research Centre
  • Synexus Thames Valley Clinical Research Centre
  • Synexus Scotland Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EBX 10

EBX 5

PLCBO

Arm Description

Elobixibat 10 mg/day

Elobixibat 5 mg/day

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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').
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 12, 2013
Last Updated
September 22, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01833065
Brief Title
Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to a distribution issue with the trial medication
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (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
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.
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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBX 10
Arm Type
Experimental
Arm Description
Elobixibat 10 mg/day
Arm Title
EBX 5
Arm Type
Experimental
Arm Description
Elobixibat 5 mg/day
Arm Title
PLCBO
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Elobixibat 10 mg/day
Other Intervention Name(s)
A3309
Intervention Description
Elobixibat 10 mg/day
Intervention Type
Drug
Intervention Name(s)
Elobixibat 5 mg/day
Other Intervention Name(s)
A3309
Intervention Description
Elobixibat 5 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Overall Complete Spontaneous Bowel Movement (CSBM) Response
Description
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.
Time Frame
During the first 12 weeks
Secondary Outcome Measure Information:
Title
Occurrence of CSBM Response
Description
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').
Time Frame
Within first 24 hours of treatment initiation
Title
Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)
Description
The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.
Time Frame
From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Title
Change From Baseline in Weekly Stool Consistency of SBMs
Description
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.
Time Frame
From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Title
Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder
Description
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.
Time Frame
At Week 12
Title
Change From Baseline in Weekly Degree of Straining of SBMs
Description
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.
Time Frame
From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Title
Change From Baseline in Weekly Abdominal Bloating Score
Description
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.
Time Frame
From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Title
Change From Baseline in Weekly Abdominal Discomfort Score
Description
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.
Time Frame
From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
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
Birmingham Gastroenterology Associates, PC
City
Birmingham
State/Province
Alabama
Country
United States
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
David Geffen School of Medicine at University of California, Los Angeles
City
Los Angeles
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
Precision Research Institute, LLC
City
San Diego
State/Province
California
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
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
Sanitas Research
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
Lake Internal Medicine Associates
City
Eustis
State/Province
Florida
Country
United States
Facility Name
Health Care Family Rehab Corp.
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Southeast Clinical Research, LLC
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Premier Healthcare Research, LLC
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Rockford Gastroenterology Associates, Ltd.
City
Rockford
State/Province
Illinois
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
Professional Research Network of Kansas, LLC
City
Witchita
State/Province
Kansas
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
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
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Carolina Digestive Health Associates, PA
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Carolina Digestive Health Associates, PA
City
Concord
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
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Hometown Urgent Care and Occupational Health
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Hometown Urgent Care and Occupational Health
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Family Practice Center of Wadsworth
City
Wadsworth
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
Anderson Gastroenterology Associates
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
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
New Phase Research and Development, LLC
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Across America
City
Katy
State/Province
Texas
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Fundacao IMEPEM - Universidade Federal de Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
Country
Brazil
Facility Name
Gastrocentro Carioca Centro Gast e Endosc Dig, Ltda
City
Rio de Janeiro
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
Country
Brazil
Facility Name
Medical Arts Health Research Group
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
London Road Diagnostic Clinic and Medical Centre
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Dr Anil K Gupta Medicine Professional Corp.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Digestive Diseases Associates, Inc.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pro-Recherche Polyclinique des Ponts
City
Saint Romuald
State/Province
Quebec
Country
Canada
Facility Name
Fakultní Nemocnice Ostrava
City
Ostrava
State/Province
Severomoravsky Kraj
Country
Czech Republic
Facility Name
Gastroenterologicka a interni ambulance
City
Ceské Budejovice
Country
Czech Republic
Facility Name
Synexus Clinical Research GmbH
City
Magdeburg
State/Province
Sachsen-anhalt
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Görlitz
State/Province
Sachsen
Country
Germany
Facility Name
Pándy Kálmán Megyei Kórház
City
Gyula
State/Province
Bekes
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
City
Budapest
Country
Hungary
Facility Name
Pannónia Magánorvosi Centrum Kft.
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft
City
Debrecen
Country
Hungary
Facility Name
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Facility Name
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház
City
Miskolc
Country
Hungary
Facility Name
Clinfan Szolgáltató Kft
City
Szekszárd
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Szikszó
Country
Hungary
Facility Name
Jávorszky Ödön Kórház
City
Vác
Country
Hungary
Facility Name
Centro de Investigación Médico Biológica y Terapia Avanzada SC
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Accelerium Clinical Research
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Medical Care and Research
City
Mérida
State/Province
Yucatan
Country
Mexico
Facility Name
Hospital Centro Internacional de Medicina Chihuahua
City
Chihuahua
Country
Mexico
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Adam Kopon
City
Torun
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lódz
State/Province
Lodzkie
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Kraków
State/Province
Malopolskie
Country
Poland
Facility Name
Medica Pro Familia Sp. z o.o. S.K.A.
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Medicor Centrum Medyczne Tadeusz Mazurek
City
Rzeszów
State/Province
Podkarpackie
Country
Poland
Facility Name
Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
City
Bratislava
Country
Slovakia
Facility Name
PIGEAS s.r.o.
City
Martin
Country
Slovakia
Facility Name
KM Management sro
City
Nitra
Country
Slovakia
Facility Name
Gastro I.s.r.o.
City
Prešov
Country
Slovakia
Facility Name
GEA s.r.o Gastroenterologicka ambulancia
City
Trnava
Country
Slovakia
Facility Name
JOSHA Research
City
Bloemfontein
State/Province
Free State
Country
South Africa
Facility Name
Synexus Clinical Research SA
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Dr. Zubar Fazel Vawda
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middelburg
State/Province
Mpumalanga
Country
South Africa
Facility Name
Louis Leipoldt Medi-Clinic Medical Centre
City
Bellville
State/Province
Western Cape
Country
South Africa
Facility Name
Be Part Yoluntu Centre
City
Paarl
State/Province
Western Cape
Country
South Africa
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
Facility Name
Uppsala Akademiska Sjukhus
City
Uppsala
Country
Sweden
Facility Name
Synexus Lancashire Clinical Research Centre
City
Chorley
State/Province
England
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
State/Province
England
Country
United Kingdom
Facility Name
Synexus Thames Valley Clinical Research Centre
City
Reading
State/Province
England
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
State/Province
Scotland
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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