E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic idiopathic constipation |
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E.1.1.1 | Medical condition in easily understood language |
Chronic idiopathic constipation is a condition of infrequent bowel movements and difficult passage of stools which does not go away |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072118 |
E.1.2 | Term | Chronic idiopathic constipation |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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).
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 The patient has been withdrawn/discontinued from the 000079 or 000080 trials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.Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
c. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
d. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
e. Sexual abstinence
4. The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 1 to 6 and 5 Phone Contacts (weeks 1, 4, 18, 30 and 44) |
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E.5.2 | Secondary end point(s) |
•Use of concomitant over-the-counter laxatives
•Global evaluation of constipation severity and treatment effectiveness
•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'
•EuroQol Group 5 Dimensions Questionnaire/EuroQol Group Visual Analogue Scale (EQ-5D-5L/EQ VAS) scores
•Health Care Resource Use (HRU) score
•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 |
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E.5.2.1 | 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)
• HRU score at Visits 1-5
• Remaining secondary endpoints: At 12, 24, 36, and 52 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Brazil |
Canada |
Czech Republic |
Germany |
Hungary |
Israel |
Mexico |
Poland |
Slovakia |
South Africa |
Sweden |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |