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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 9, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00171457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Heartburn
Dyspepsia

Intervention ^ICMJE

Drug: Tegaserod

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00171457

Responsible Party

Study ID Numbers ^ICMJE

CHTF919DUS45

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP