Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS|
- Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
- Weekly assessment of patient's overall satisfaction relief.
- Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
- During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
- Assessment of safety and tolerability.
|Study Start Date:||April 2004|
|Study Completion Date:||June 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142987
|Study Chair:||Novartis||East Hanover NJ|