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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171457

Enrollment

Registered

2005-09-15

Start date

2005-04-30

Completion date

2006-09-30

Last updated

2007-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Heartburn

Keywords

functional heartburn, dyspepsia, male, female, visceral sensitivity

Brief summary

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

Interventions

DRUGTegaserod

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—
1) Comparing effects at end of treatment compared to baseline:	—
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	—
To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026