Irritable Bowel Syndrome
Conditions
Brief summary
Abdominal Pain Intensity, Global Relief of Symptoms
Detailed description
Overall Response (Abdominal Pain Intensity & Global Relief of Symptoms): Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Weekly Response up to Week 12, Weekly Response during Run-Out Period, Clinical Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 3 weeks during the last 6 weeks of treatment, Overall Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Abdominal Pain Intensity Weekly Response up to Week 12, Weekly average Abdominal Pain Intensity Scores up to Week 12, %Change in weekly average Abdominal Pain Intensity Scores up to Week 12, Weekly average Abdominal Pain Intensity Scores during Run-Out period, Clinical Global Symptom Relief response: weekly responder for >= 3 weeks during the last 6 weeks of treatment, Overall Global Symptom Relief response: weekly responder for >= 6 weeks during the 12 weeks of treatment, Weekly Global Symptom Relief Response up to Week 12, Weekly Global Symptom Relief during Run-Out Period, Overall Stool Consistency Response: Stool Consistency Weekly responder for >= 6 weeks, Clinical Stool Consistency response: Stool Consistency Weekly Responder for >=3 weeks during the last 6 weeks of treatment, Stool Consistency Weekly Response up to Week 12, Weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12, Weekly number of days with at least 1 stool of consistency 6 or 7 during Run-Out Period, %Change in weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12, IBS-SSS score: score between 0 and 500 assessed at baseline and at 12 weeks; IBS-SSS Score and change in score at 12 weeks; IBS-SSS response: decrease >= 50 points, Quality of Life at Week 12
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal Pain Intensity, Global Relief of Symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response (Abdominal Pain Intensity & Global Relief of Symptoms): Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Weekly Response up to Week 12, Weekly Response during Run-Out Period, Clinical Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 3 weeks during the last 6 weeks of treatment, Overall Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Abdominal Pain Intensity Weekly Response up to Week 12, Weekly average Abdominal Pain Intensity Scores up to Week 12, %Change in weekly average Abdominal Pain Intensity Scores up to Week 12, Weekly average Abdominal Pain Intensity Scores during Run-Out period, Clinical Global Symptom Relief response: weekly responder for >= 3 weeks during the last 6 weeks of treatment, Overall Global Symptom Relief response: weekly responder for >= 6 weeks during the 12 weeks of treatment, Weekly Global Symptom Relief Response up | — |
Countries
Belgium