A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

August 31, 2010 updated by: Novartis
Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

832

Phase

  • Phase 2

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

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936-108
        • Novartis

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:

  • History of physician diagnosed GERD
  • Heartburn and Regurgitation 3 Days during the week prior to screening

Exclusion Criteria:

  • History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
  • History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
  • Use of PPI during the last four weeks prior to screening

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
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
Decreasing frequency of regurgitation during week 4 of treatment
Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

Collaborators and Investigators

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

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, East Hanover NJ

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

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

September 1, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTF919B2203

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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