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Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

Primary Purpose

Chronic Constipation

Status
Completed
Phase
Phase 3
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 Chronic Constipation focused on measuring Male patients, chronic constipation, tegaserod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: A 6-month history of constipation defined as <3 complete spontaneous bowel movements per week and >1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining Exclusion Criteria: Patients with cancer, inflammatory bowel disease or other structural bowel disease Past or current diagnosis of irritable bowel syndrome were excluded. Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.

    Secondary Outcome Measures

    For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
    Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
    Safety and tolerability.

    Full Information

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

    Unique Protocol Identification Number
    NCT00141089
    Brief Title
    Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
    Official Title
    Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Constipation
    Keywords
    Male patients, chronic constipation, tegaserod

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    1026 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tegaserod
    Primary Outcome Measure Information:
    Title
    Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
    Secondary Outcome Measure Information:
    Title
    For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
    Title
    Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
    Title
    Safety and tolerability.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: A 6-month history of constipation defined as <3 complete spontaneous bowel movements per week and >1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining Exclusion Criteria: Patients with cancer, inflammatory bowel disease or other structural bowel disease Past or current diagnosis of irritable bowel syndrome were excluded. Other protocol-defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis Basel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

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