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

This study has been completed.

First Received: September 12, 2005 Last Updated: October 9, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171457

Purpose

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

Condition	Intervention	Phase
Heartburn Dyspepsia	Drug: Tegaserod	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

Resource links provided by NLM:

MedlinePlus related topics: Heartburn Indigestion

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	24
Study Start Date:	April 2005
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171457

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. Epub 2008 Jun 17.

Study ID Numbers:	CHTF919DUS45
Study First Received:	September 12, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00171457 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

functional heartburn
dyspepsia
male
female
visceral sensitivity

Additional relevant MeSH terms:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive

Physiological Effects of Drugs
Heartburn
Dyspepsia
Pharmacologic Actions
Tegaserod

ClinicalTrials.gov processed this record on November 30, 2009