Back to resultsThe Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Primary Purpose
Heartburn, Dyspepsia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Heartburn focused on measuring functional heartburn, dyspepsia, male, female, visceral sensitivity
Eligibility 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.
Sites / Locations
- Oklahoma Foundation for Digestive Research
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171457
Brief Title
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Official Title
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn, Dyspepsia
Keywords
functional heartburn, dyspepsia, male, female, visceral sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
Secondary Outcome Measure Information:
Title
1) Comparing effects at end of treatment compared to baseline:
Title
To verify that tegaserod modulates esophageal sensitivity to esophageal distention
Title
To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
Title
To determine if tegaserod improves heartburn and/or regurgitation
Title
To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
Title
Safety assessment
Title
To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18561877
Citation
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. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.
Results Reference
derived
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The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
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