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

Novartis54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

TegaserodDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Drug Research Services, Inc

Metairie, Louisiana, United States

The Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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