Clinical trial NCT01895543: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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* The patient has been withdrawn/discontinued from the 000079 or 000080 trials.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

  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.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: For the overall 52-week Treatment Period
measure: Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables
timeFrame: For the overall 52-week Treatment Period
measure: Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)
timeFrame: For the overall 52-week Treatment Period
measure: Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs
timeFrame: For the overall 52-week Treatment Period
measure: Number of Patients Using Concomitant Medications
timeFrame: For the overall 52-week Treatment Period
Secondary outcomes:
measure: Use of Concomitant Over-the-counter (OTC) Laxatives
timeFrame: For the overall 52-week Treatment Period
measure: Change From Baseline in Global Evaluation of Constipation Severity
timeFrame: At Week 12, 24, 36, and 52
measure: Change From Baseline in Global Evaluation of Treatment Effectiveness
timeFrame: At Week 12, 24, 36, and 52
measure: Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score
timeFrame: At Week 12, 24, 36 and 52
measure: Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores
timeFrame: At Week 12, 24, 36 and 52
measure: Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score
timeFrame: At Week 12, 24, 36 and 52
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Cerritos
country: United States
facility: Skyline Research, LLC
state: California
city: Los Angeles
country: United States
facility: West Gastroenterology Associates
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Group
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Boynton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brandon
country: United States
facility: Pulmonary Associates of Brandon
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab Corp.
state: Florida
city: Hialeah
country: United States
facility: Medsearch Professional Group, Inc.
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Center for Gastrointestinal Disorders
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research Inc.
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Newington
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Concord
country: United States
facility: Carolina Digestive Health Associates, PA
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest, LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Associates, LLC
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Pittsburg
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Gastroenterology Associates
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology, LLC
state: Tennessee
city: Jackson
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc (there may be other sites in this country)
city: Toronto
country: Canada
facility: Prime Health Clinical Research Organization (there may be other sites in this country)
state: Ontario
city: Hradec Králové
country: Czech Republic
facility: Gastroenterologie, s. r. o. (there may be other sites in this country)
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)
city: Lódz
country: Poland
facility: SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)
state: Lodzkie
city: Nitra
country: Slovakia
facility: KM Management sro (there may be other sites in this country)
city: Bellville
country: South Africa
facility: Louise Lelpoldt Medical Centre (there may be other sites in this country)
state: Western Cape
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhus (there may be other sites in this country)
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre (there may be other sites in this country)
state: England
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: