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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171457
• Other study ID #: CHTF919DUS45
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 9, 2007
• Start date: April 2005
• Est. completion date: September 2006

Study information

• Verified date: October 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Heartburn

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
Secondary	1) Comparing effects at end of treatment compared to baseline:
Secondary	To verify that tegaserod modulates esophageal sensitivity to esophageal distention
Secondary	To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
Secondary	To determine if tegaserod improves heartburn and/or regurgitation
Secondary	To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
Secondary	Safety assessment
Secondary	To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi