Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

January 24, 2008 updated by: Novartis
Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Consultants for Clinical Research of South Florida
      • Miami, Florida, United States, 33173
        • Miami Research Associates
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Department of Internal Medicine - Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53207
        • The Wisconsin Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heartburn for at least 3 days in the week prior to screening
  • Regurgitation for at least 3 days in the week prior to screening
  • Stable dose PPI therapy > 4 weeks
  • Incomplete relief on daily PPI therapy > 4 weeks

Exclusion Criteria:

  • Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
  • Previous gastrointestinal surgery that may influence esophageal motor function
  • Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)

Secondary Outcome Measures

Outcome Measure
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
To assess patient satisfaction with treatment (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 28, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

January 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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