Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
NCT ID: NCT01895543
Last Updated: 2016-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
411 participants
INTERVENTIONAL
2013-09-30
2015-05-31
Brief Summary
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Detailed Description
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The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EBX10
Elobixibat 10 mg
Elobixibat 10 mg
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
Interventions
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Elobixibat 10 mg
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Genova Clinical Research, Inc.
Tucson, Arizona, United States
Preferred Research Partners
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
Countries
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Other Identifiers
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2012-005601-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000081
Identifier Type: -
Identifier Source: org_study_id
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