Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.
The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 26-week Treatment Period in patients with chronic idiopathic constipation. Patients were followed-up for 2 weeks after end of the Treatment Period. The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of Treatment Period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the treatment. The trial was early terminated due to a distribution issue with the trial medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
376
Overall Complete Spontaneous Bowel Movement (CSBM) Response
This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was 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 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.
Time frame: During the first 12 weeks
Occurrence of CSBM Response
This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').
Time frame: Within the first 24 hours of treatment initiation
Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)
The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.
Time frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Change From Baseline in Weekly Stool Consistency of SBMs
The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly. Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea . For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
G and L Research, LLC
Foley, Alabama, United States
Adobe Gastroenterology Research, LLC
Tucson, Arizona, United States
Skyline Research LLC
Cerritos, California, United States
GW Research, Inc.
Chula Vista, California, United States
Paradigm Clinical, Inc.
Garden Grove, California, United States
Providence Clinical Research
North Hollywood, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Pulmonary Associates of Brandon
Brandon, Florida, United States
In Vivo Clinical Research, Inc.
Hialeah, Florida, United States
...and 84 more locations
Time frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder
This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12. PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 \[none of the time or not at all\] to 4 \[all of the time or extremely\]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation. Total PAC-QOL score was averaged from the individual item score.
Time frame: At 12 weeks
Change From Baseline in Weekly Degree of Straining of SBMs
The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount). For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Time frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Change From Baseline in Weekly Abdominal Bloating Score
The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe). For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Time frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period
Change From Baseline in Weekly Abdominal Discomfort Score
The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe). For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model.
Time frame: From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period