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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171457

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heartburn Dyspepsia	Drug: Tegaserod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.