Official Title: “The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

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

Secondary 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171457

Study ID Number: CHTF919DUS45

ClinicalTrials.gov Identifier: NCT00171457

Health Authority: United States: Food and Drug Administration