Chronic idiopathic constipation MedDRA version: 16.1 Level: LLT Classification code 10072118 Term: Chronic idiopathic constipation System Organ Class: 100000004856
Conditions
Sponsors
Ferring International Pharmascience Center US, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments 2.The patient is a male or female =18 years of age 3.The patient has a body mass index (BMI) =18.5 but =65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: 1.The patient reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7) in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of BMs during the 12 weeks prior to the Screening Visit 2.The patient reports a BSFS of 6 or 7 on any day during the Pretreatment Period, unless this occurred within 24 hours of having taken rescue medication. 3.The patient has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms as defined by the Rome III criteria: reports abdominal discomfort or pain that has two or more of the following three features the last 3 months with symptom onset at least 6 months before the Screening Visit: a.Improvement with defecation b.Onset associated with a change in frequency of stool c.Onset associated with a change in form (appearance) of stool 4.The patient has a structural abnormality of the GI tract or a disease or condition that can affect GI motility. 5. The patient has a history of any gastro-intestinal disease not considered to be CIC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To demonstrate the efficacy of repeated daily doses of 5 mg and 10 mg elobixibat on other bowel movement (BM) parameters, CIC symptoms, constipation affected work productivity and activity impairment, health care resource use, and patient assessments of effectiveness based on selected quality of life measurements. To assess the safety and tolerability of repeated daily doses of 5 mg and 10 mg elobixibat for 26 weeks in patients with CIC. ;Primary end point(s): The primary efficacy endpoint is the overall CSBM Response, where a responder is defined as a patient with =3 CSBMs per week and an increase of =1 CSBM per week from Baseline, for at least 9 of the first 12 weeks of the 26-week Treatment Period, including at least 3 weeks in Weeks 9-12.;Timepoint(s) of evaluation of this end point: At 12 weeks;Main Objective: To demonstrate the efficacy, as determined by overall complete spontaneous bowel movement (CSBM) response, of repeated daily doses of 5 mg and 10 mg elobixibat for the first 12 weeks in patients with chronic idiopathic constipation (CIC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Occurrence of a CSBM within 24 hours of treatment initiation •Change from Baseline in weekly frequency of spontaneous bowel movements (SBMs) for the overall first 12 weeks of the 26-week Treatment Period •Change from Baseline in weekly stool consistency of SBMs for the overall first 12 weeks of the 26-week Treatment Period •Total PAC-QOL score responder at Week 12 •Change from Baseline in weekly degree of straining of SBMs for the overall first 12 weeks of the 26-week Treatment Period •Change from Baseline in weekly abdominal bloating score for the overall first 12 weeks of the 26-week Treatment Period •Change from Baseline in weekly abdominal discomfort score for the overall first 12 weeks of the 26-week Treatment Period •Safety: adverse events (AEs), clinical safety laboratory variables (haematology, clinical chemistry, urinalysis), ECGs, vital signs, and concomitant medications;Timepoint(s) of evaluation of this end point: Safety: at visits 2-11 | — |
Countries
Belgium, Brazil, Canada, Czech Republic, Germany, Israel, Poland, South Africa, United Kingdom, United States
Contacts
Public ContactClinincal Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed