Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs). - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

January 24, 2008

Start Date ^†

June 2003

Current Primary Outcome Measures ^†

To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00171418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Safety assessment

Original Secondary Outcome Measures ^†

To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Safety assessment

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Gastroesophageal Reflux Disease (GERD)

Intervention ^†

Drug: Tegaserod

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

GERD symptoms for at least 6 months
PPI therapy for at least 4 weeks
Incomplete symptom relief on daily PPI therapy
No erosive disease as evidenced in EGD/no change in symptom severity

Exclusion Criteria:

Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
Previous gastrointestinal surgery that may influence esophageal motor function
Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171418

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.