Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation (Echo 3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01895543
First received: June 28, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Elobixibat 10 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: Yes ]
  • Incidence of markedly abnormal changes in clinical safety laboratory variables [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: Yes ]
  • Incidence of markedly abnormal changes in electrocardiograms (ECGs) [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: Yes ]
  • Incidence of markedly abnormal changes in body weight and vital signs [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: Yes ]
  • Number and percentage of patients using concomitant medications [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of concomitant over-the-counter laxatives [ Time Frame: For the overall 52 weeks period and the 2 weeks Follow-up Visit ] [ Designated as safety issue: No ]
  • Global evaluation of constipation severity and treatment effectiveness on a 5-point scale [ Time Frame: At week 12, 24, 36, and 52 ] [ Designated as safety issue: No ]
  • 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' [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: No ]
  • EuroQol Group 5 Dimensions Questionnaire/EuroQol Group Visual Analogue Scale (EQ-5D-5L/EQ VAS) scores and in corresponding quality-adjusted life-years (QALYs) [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: No ]
  • Health Care Resource Use Questionnaire (HRUQ) score at visits 1-5 [ Time Frame: For the overall 52 weeks period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Week 12, 24, 36, and 52 ] [ Designated as safety issue: No ]

Enrollment: 411
Study Start Date: September 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBX10
Elobixibat 10 mg
Drug: Elobixibat 10 mg
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895543

  Show 62 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01895543     History of Changes
Other Study ID Numbers: 000081, 2012-005601-46
Study First Received: June 28, 2013
Last Updated: October 10, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014