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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heartburn; Dyspepsia

Intervention: Tegaserod (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Summary

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

Clinical Details

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma 73104, United States
Additional Information

Starting date: April 2005
Last updated: October 9, 2007

Page last updated: August 23, 2015

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