The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

Phase 3CompletedNCT00171457

Novartis24 enrolled

Overview

Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heartburn Dyspepsia

Interventions

TegaserodDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects at least 18 years of age. * Subjects willing to undergo multiple nasogastric intubations. * Patients with functional heartburn will need to meet ROME II criteria. * Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety) Exclusion Criteria: * Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS. * Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease. * Subjects with Diffuse Esophageal Spasm or Achalasia. Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach

Secondary Outcomes

1) Comparing effects at end of treatment compared to baseline:

To verify that tegaserod modulates esophageal sensitivity to esophageal distention

To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort

To determine if tegaserod improves heartburn and/or regurgitation

To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo

Safety assessment

To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi

Data from ClinicalTrials.gov

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