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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Tegaserod

Criteria

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.