LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RELIANCE)
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
Irritable Bowel Syndrome
|Study Design:||Time Perspective: Prospective|
|Official Title:||Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment|
- Change in stool consistency [ Time Frame: At Week 4 and Week 12 ] [ Designated as safety issue: No ]Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.
- IBS pain severity [ Time Frame: At Weeks 4 and 12 ] [ Designated as safety issue: No ]Pain intensity as measured by the 11-point numeric rating scale (NRS) will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined.
- Change from baseline in quality of life scores (IBSQOL). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Change from baseline in IBSQOL scores will be calculated at Week 12.
- Change from baseline stool frequency. [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]Stool frequency will be measured as the mean number of times per day that stools were passed, and will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined
- Change from baseline in fecal urgency. [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]Proportion of days with fecal urgency will be calculated for each 4-week interval and change from baseline will be determined at 4 and 12 weeks.
- Change from baseline in lost productivity. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Lost workplace productivity and number of days IBS symptoms interfered with social/leisure and household activities will be determined at baseline and week 12. Change from baseline to week 12 will be calculated.
|Study Start Date:||November 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
This observational study will evaluate the effect of Lotronex® as used in the current clinical practice setting on symptom relief, specifically, improvement in bowel habits and IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be consented for study participation. Patients will complete study questionnaires related to bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome. Investigators will also be asked to complete questionnaires related to the patient's disease characteristics, patient progress on study medication and treatment outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257477
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|Study Director:||Emil Chuang, MD||Prometheus Therapeutics and Diagnostics|