Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
|ClinicalTrials.gov Identifier: NCT01895543|
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Idiopathic Constipation||Drug: Elobixibat 10 mg||Phase 3|
This was a Phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week Treatment Period in patients with CIC. A dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment.
The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||411 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Elobixibat 10 mg
Drug: Elobixibat 10 mg
10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
- Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: For the overall 52-week Treatment Period ]The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.
- Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables [ Time Frame: For the overall 52-week Treatment Period ]Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry
- Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs) [ Time Frame: For the overall 52-week Treatment Period ]A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.
- Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs [ Time Frame: For the overall 52-week Treatment Period ]Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.
- Number of Patients Using Concomitant Medications [ Time Frame: For the overall 52-week Treatment Period ]The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.
- Use of Concomitant Over-the-counter (OTC) Laxatives [ Time Frame: For the overall 52-week Treatment Period ]The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).
- Change From Baseline in Global Evaluation of Constipation Severity [ Time Frame: At Week 12, 24, 36, and 52 ]The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).
- Change From Baseline in Global Evaluation of Treatment Effectiveness [ Time Frame: At Week 12, 24, 36, and 52 ]The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).
- Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score [ Time Frame: At Week 12, 24, 36 and 52 ]PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 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 QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: 'Worries and Concerns', 'Physical Discomfort', 'Psychosocial Discomfort', and 'Dissatisfaction'.
- Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores [ Time Frame: At Week 12, 24, 36 and 52 ]EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.
- Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score [ Time Frame: At Week 12, 24, 36 and 52 ]The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate "how his/her health is TODAY" and mention the same number in a box provided.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895543
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|