A drug trial to test the safety and tolerability of elobixibat 5 mg and 10 mg taken every day for chronic constipatio

• Conditions: Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Chronic idiopathic constipation; MedDRA version: 16.1Level: LLTClassification code 10072118Term: Chronic idiopathic constipationSystem Organ Class: 100000004856

• Registration Number: EUCTR2012-005601-46-BE
• Lead Sponsor: Ferring International Pharmascience Center US, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-26
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. The patient has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080
2. The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments
3. The patient agrees to refrain from making any new, major life-style 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1. The patient has been withdrawn/discontinued from the 000079 or 000080 trials
2. The patient is not willing to abide by the restrictions for intake of prohibited medication
3. 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
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:
a. Transdermal patch.
b. Established use of oral, injected or implanted hormonal methods of
contraception.
c. Placement of an intrauterine device (IUD) or intrauterine system
(IUS).
d. Barrier methods of contraception: Condom or Occlusive cap
(diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository.
e. Male sterilisation (with the appropriate post-vasectomy
documentation of the absence of sperm in the ejaculate).
f. True sexual abstinence: when this is in line with the preferred and
usual lifestyle of the patient.
4. The patients is considered by the Investigator to be unsuitable to
participate in the trial for any other reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified