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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

Primary Purpose

IBS-C and IBS With Mixed Bowel Habits

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS-C and IBS With Mixed Bowel Habits focused on measuring Tegaserod, IBS-C, women, mixed bowel habit

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)Female

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    August 31, 2005
    Last Updated
    January 24, 2008
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00142987
    Brief Title
    Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
    Official Title
    Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IBS-C and IBS With Mixed Bowel Habits
    Keywords
    Tegaserod, IBS-C, women, mixed bowel habit

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    664 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tegaserod
    Primary Outcome Measure Information:
    Title
    Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
    Secondary Outcome Measure Information:
    Title
    Weekly assessment of patient's overall satisfaction relief.
    Title
    Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
    Title
    During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
    Title
    Assessment of safety and tolerability.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    East Hanover NJ
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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