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

Phase 3

Completed

• Conditions: Dyspepsia; Heartburn

• Registration Number: NCT00171457
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Study Completion: 2006-09
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-09
• Last Update Posted: 2007-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1) Comparing effects at end of treatment compared to baseline:
To determine if tegaserod improves heartburn and/or regurgitation
To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
To verify that tegaserod modulates esophageal sensitivity to esophageal distention
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

Trial Locations

Locations (1)

Oklahoma Foundation for Digestive Research; 🇺🇸 Oklahoma City, Oklahoma, United States