The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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
Ending date: September 2006
Last updated: October 9, 2007
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