Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

— Echo 3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895543
• Other study ID #: 000081
• Secondary ID: 2012-005601-46
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2013
• Last updated: May 20, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 life-style changes that may affect Chronic Idiopathic Constipation (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• The patient has been withdrawn/discontinued from the 000079 or 000080 trials.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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Elobixibat 10 mg
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc (there may be other sites in this country)	Brussels
Canada	Prime Health Clinical Research Organization (there may be other sites in this country)	Toronto	Ontario
Czech Republic	Gastroenterologie, s. r. o. (there may be other sites in this country)	Hradec Králové
Hungary	Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)	Budapest
Poland	SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)	Lódz	Lodzkie
Slovakia	KM Management sro (there may be other sites in this country)	Nitra
South Africa	Louise Lelpoldt Medical Centre (there may be other sites in this country)	Bellville	Western Cape
Sweden	Uppsala Akademiska Sjukhus (there may be other sites in this country)	Uppsala
United Kingdom	Synexus Merseyside Clinical Research Centre (there may be other sites in this country)	Liverpool	England
United States	Anderson Gastroenterology Associates	Anderson	South Carolina
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Zasa Clinical Research	Boynton Beach	Florida
United States	Meridien Research	Bradenton	Florida
United States	Pulmonary Associates of Brandon	Brandon	Florida
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Skyline Research, LLC	Cerritos	California
United States	ClinSearch	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	TriHealth, Inc.	Cincinnati	Ohio
United States	Carolina Digestive Health Associates, PA	Concord	North Carolina
United States	KRK Medical Research	Dallas	Texas
United States	Evanston Hospital	Evanston	Illinois
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Memphis Gastroenterology Group, PC	Germantown	Tennessee
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	PharmQuest, LLC	Greensboro	North Carolina
United States	Associates in Gastroenterology, LLC	Hermitage	Tennessee
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	Peters Medical Research, LLC	High Point	North Carolina
United States	Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Nature Coast Clinical Research, LLC	Inverness	Florida
United States	HCCA Clinical Research Solutions	Jackson	Tennessee
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Jupiter Research Inc.	Jupiter	Florida
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Preferred Research Partners	Little Rock	Arkansas
United States	West Gastroenterology Associates	Los Angeles	California
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Research Institute of South Florida	Miami	Florida
United States	ActivMed Practices and Research, Inc.	Newington	New Hampshire
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Clinical Research Associates, LLC	Oklahoma City	Oklahoma
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Clinical Trials Research Services, LLC	Pittsburg	Pennsylvania
United States	Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
United States	Sacramento Research Medical Group	Sacramento	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Georgia Clinical Research	Snellville	Georgia
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Pioneer Research Solutions, Inc.	Sugar Land	Texas
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Hungary,  Poland,  Slovakia,  South Africa,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs)		For the overall 52 weeks period	Yes
Primary	Incidence of markedly abnormal changes in clinical safety laboratory variables		For the overall 52 weeks period	Yes
Primary	Incidence of markedly abnormal changes in electrocardiograms (ECGs)		For the overall 52 weeks period	Yes
Primary	Incidence of markedly abnormal changes in body weight and vital signs		For the overall 52 weeks period	Yes
Primary	Number and percentage of patients using concomitant medications		For the overall 52 weeks period	Yes
Secondary	Use of concomitant over-the-counter laxatives		For the overall 52 weeks period and the 2 weeks Follow-up Visit	No
Secondary	Global evaluation of constipation severity and treatment effectiveness on a 5-point scale		At week 12, 24, 36, and 52	No
Secondary	Change from Baseline in total Patient assessment of constipation - Quality of Life (PAC-QOL) score and in the 4 psychometric subscales, 'Worries and Concerns', 'Physical Discomfort', 'Psychosocial Discomfort', and 'Dissatisfaction'		For the overall 52 weeks period	No
Secondary	EuroQol Group 5 Dimensions Questionnaire/EuroQol Group Visual Analogue Scale (EQ-5D-5L/EQ VAS) scores and in corresponding quality-adjusted life-years (QALYs)		For the overall 52 weeks period	No
Secondary	Health Care Resource Use Questionnaire (HRUQ) score at visits 1-5		For the overall 52 weeks period	No
Secondary	Change from Baseline in Work Productivity and Activity Impairment Questionnaire for Constipation (WPAI:C) score for absenteeism, presenteeism, overall productivity loss, and daily activity impairment		At Week 12, 24, 36, and 52	No