Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Ferring Pharmaceuticals411 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

411

Conditions

Chronic Idiopathic Constipation

Interventions

Elobixibat 10 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * The patient has been withdrawn/discontinued from the 000079 or 000080 trials.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

Locations (62)

Outcomes

Primary Outcomes

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.