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The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

Primary Purpose

Constipation and Dyspepsia

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Withdrawn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

About this trial

This is an interventional treatment trial for Constipation and Dyspepsia focused on measuring Constipation, Tegaserod, Dyspepsia

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Females aged 18 to 64 years of age Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study: Less than 3 bowel movements per week Hard or lumpy stools Straining during bowel movements Feeling of incomplete evacuation Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating Exclusion Criteria: Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians Patients with constipation secondary to medication use as determined by the study physician Patients with clinically significant abnormal TSH levels at screening Patients that have heartburn or abdominal pain as their predominant GI symptom Evidence of cathartic colon or a history of laxative abuse Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.

    Secondary Outcome Measures

    To evaluate the PD effects of tegaserod on upper & lower GI transit
    To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments

    Full Information

    First Posted
    January 13, 2006
    Last Updated
    March 2, 2016
    Sponsor
    Novartis
    Collaborators
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00277550
    Brief Title
    The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
    Official Title
    A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis
    Collaborators
    Mayo Clinic

    4. Oversight

    5. Study Description

    Brief Summary
    To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation and Dyspepsia
    Keywords
    Constipation, Tegaserod, Dyspepsia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tegaserod and Placebo
    Primary Outcome Measure Information:
    Title
    To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
    Secondary Outcome Measure Information:
    Title
    To evaluate the PD effects of tegaserod on upper & lower GI transit
    Title
    To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females aged 18 to 64 years of age Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study: Less than 3 bowel movements per week Hard or lumpy stools Straining during bowel movements Feeling of incomplete evacuation Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating Exclusion Criteria: Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians Patients with constipation secondary to medication use as determined by the study physician Patients with clinically significant abnormal TSH levels at screening Patients that have heartburn or abdominal pain as their predominant GI symptom Evidence of cathartic colon or a history of laxative abuse Other protocol-defined inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicholas Talley, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michael Crowell, PhD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

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