Clinical Trial: The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Brief Summary: Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
Original Primary Outcome:
Current Secondary Outcome:
- 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
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 12, 2005
Date Started: April 2005
Date Completion:
Last Updated: October 9, 2007
Last Verified: October 2007
