A drug trial to test the safety and tolerability of elobixibat 5 mg and 10 mg taken every day for chronic constipatio
- Conditions
- Chronic idiopathic constipationMedDRA version: 17.1Level: LLTClassification code 10072118Term: Chronic idiopathic constipationSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-005601-46-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 411
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 274
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 137
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 The patient has been withdrawn/discontinued from the 000079 or 000080 trials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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and tolerability of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52 weeks in patients diagnosed with chronic idiopathic constipation (CIC). <br>;Secondary Objective: To assess the treatment efficacy and treatment satisfaction including effects on Health Related Quality of Life (HRQoL), health care resource use, constipation affected work productivity and activity impairment, and the use of concomitant over-the-counter laxatives. ;Primary end point(s): Safety: adverse events (AEs), serious adverse events (SAEs), clinical safety laboratory variables (haematology, clinical chemistry, urinalysis), electrocardiograms (ECGs), physical examination, body weight, vital signs, and concomitant medications.;Timepoint(s) of evaluation of this end point: Visit 1 to 6 and 5 Phone Contacts (weeks 1, 4, 18, 30 and 44)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Use of concomitant over-the-counter laxatives<br>•Global evaluation of constipation severity and treatment effectiveness <br>•Change from Baseline in total Patient assessment of constipation – Quality of Life (PAC-QOL) score and changes from Baseline in the 4 psychometric subscales, 'Worries and Concerns', 'Physical Discomfort', 'Psychosocial Discomfort', and 'Dissatisfaction' <br>•EuroQol Group 5 Dimensions Questionnaire/EuroQol Group Visual Analogue Scale (EQ-5D-5L/EQ VAS) scores and in corresponding QALYs<br>•Health Care Resource Use (HRU) score <br>•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 ;Timepoint(s) of evaluation of this end point: • Concomittant medication: Visit 1 to 6 and 5 Phone Contacts (weeks 1, 4, 18, 30 and 44)<br>• HRU score at Visits 1-5<br>• Remaining secondary endpoints: At 12, 24, 36, and 52 weeks<br>