Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

Conditions
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IBS-C and IBS With Mixed Bowel Habits

Intervention / Treatment
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* Drug: Tegaserod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool. Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts Exclusion Criteria: IBS-D not reporting any constipation and diarrhea criteria evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions evidence of cathartic colon or history of laxative abuse Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegaserod|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tegaserod, IBS-C, women, mixed bowel habit