Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

NCT01895543 | Completed Phase 3 Results

• 2 other identifiers: 0000812012-005601-46
• Study Type: interventional
• Target: 411
• Locations: 10 countries
• Sites: 62

Brief Summary

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (6)

• Use of Concomitant Over-the-counter (OTC) Laxatives

  For the overall 52-week Treatment Period

• Change From Baseline in Global Evaluation of Constipation Severity

  At Week 12, 24, 36, and 52

• Change From Baseline in Global Evaluation of Treatment Effectiveness

  At Week 12, 24, 36, and 52

• Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score

  At Week 12, 24, 36 and 52

• Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores

  At Week 12, 24, 36 and 52

Study Arms (1)

EBX10

EXPERIMENTAL

Elobixibat 10 mg

Drug: Elobixibat 10 mg

Interventions

Elobixibat 10 mg DRUG

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

EBX10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Transdermal patch
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (62)

Genova Clinical Research, Inc.

Tucson, Arizona, United States

Location

Preferred Research Partners

Little Rock, Arkansas, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Location

Skyline Research, LLC

Cerritos, California, United States

Location

West Gastroenterology Associates

Los Angeles, California, United States

Location

Sacramento Research Medical Group

Sacramento, California, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Location

Zasa Clinical Research

Boynton Beach, Florida, United States

Location

Meridien Research

Bradenton, Florida, United States

Location

Pulmonary Associates of Brandon

Brandon, Florida, United States

Location

Health Care Family Rehab Corp.

Hialeah, Florida, United States

Location

Medsearch Professional Group, Inc.

Hialeah, Florida, United States

Location

The Community Research of South Florida

Hialeah, Florida, United States

Location

Center for Gastrointestinal Disorders

Hollywood, Florida, United States

Location

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

Location

Health Awareness, Inc.

Jupiter, Florida, United States

Location

Jupiter Research Inc.

Jupiter, Florida, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, United States

Location

Research Institute of South Florida

Miami, Florida, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, United States

Location

Mount Vernon Clinical Research

Atlanta, Georgia, United States

Location

Georgia Clinical Research

Snellville, Georgia, United States

Location

Evanston Hospital

Evanston, Illinois, United States

Location

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Location

Boston Clinical Trials

Boston, Massachusetts, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Location

ActivMed Practices and Research, Inc.

Newington, New Hampshire, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, United States

Location

Carolina Digestive Health Associates, PA

Concord, North Carolina, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Location

PharmQuest, LLC

Greensboro, North Carolina, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, United States

Location

TriHealth, Inc.

Cincinnati, Ohio, United States

Location

Clinical Research Associates, LLC

Oklahoma City, Oklahoma, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, United States

Location

Family Medical Associates

Levittown, Pennsylvania, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

Location

Anderson Gastroenterology Associates

Anderson, South Carolina, United States

Location

ClinSearch

Chattanooga, Tennessee, United States

Location

Memphis Gastroenterology Group, PC

Germantown, Tennessee, United States

Location

Associates in Gastroenterology, LLC

Hermitage, Tennessee, United States

Location

HCCA Clinical Research Solutions

Jackson, Tennessee, United States

Location

KRK Medical Research

Dallas, Texas, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Location

Pioneer Research Solutions, Inc.

Sugar Land, Texas, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Location

Northwest Gastroenterology Associates

Bellevue, Washington, United States

Location

Cliniques Universitaires Saint Luc (there may be other sites in this country)

Brussels, Belgium

Location

Prime Health Clinical Research Organization (there may be other sites in this country)

Toronto, Ontario, Canada

Location

Gastroenterologie, s. r. o. (there may be other sites in this country)

Hradec Králové, Czechia

Location

Pannónia Magánorvosi Centrum Kft. (there may be other sites in this country)

Budapest, Hungary

Location

SPZOZ Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi (there may be other sites in this country)

Lódz, Łódź Voivodeship, Poland

Location

KM Management sro (there may be other sites in this country)

Nitra, Slovakia

Location

Louise Lelpoldt Medical Centre (there may be other sites in this country)

Bellville, Western Cape, South Africa

Location

Uppsala Akademiska Sjukhus (there may be other sites in this country)

Uppsala, Sweden

Location

Synexus Merseyside Clinical Research Centre (there may be other sites in this country)

Liverpool, England, United Kingdom

Location

MeSH Terms

Interventions

elobixibat

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 9, 2016
• Results First Posted: May 9, 2016

Record last verified: 2016-04

Locations

CA (1); HU (1); CZ (1); BE (1); ZA (1); SE (1); US (53); GB (1); SL (1); PL (1)