Phase 3
N=411
Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01895543 ↗Enrolled (actual)
411
Serious AEs
3.4%
Results posted
May 2016
Primary outcome: Primary: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 241; 14 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Elobixibat 10 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
241; 14 | — |
| PRIMARY Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables |
6; 5; 3; 3; 3; 2 | — |
| PRIMARY Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs) |
3 | — |
| PRIMARY Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs |
2; 2; 1; 1 | — |
| PRIMARY Number of Patients Using Concomitant Medications |
340 | — |
| SECONDARY Use of Concomitant Over-the-counter (OTC) Laxatives |
33; 14; 11; 6; 1 | — |
| SECONDARY Change From Baseline in Global Evaluation of Constipation Severity |
-0.2; -0.2; -0.1; -0.2 | — |
| SECONDARY Change From Baseline in Global Evaluation of Treatment Effectiveness |
-0.6; -0.6; -0.7; -0.7 | — |
| SECONDARY Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score |
-0.24; -0.21; -0.16; -0.22 | — |
| SECONDARY Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score |
0.7; 1.2; 1.0; 0.8 | — |
Summary
Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)
Eligibility 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 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:
- Transdermal patch
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- 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.
Data sourced from ClinicalTrials.gov (NCT01895543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.