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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171457
First Posted: September 15, 2005
Last Update Posted: October 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach

Condition Intervention Phase
Heartburn Dyspepsia Drug: Tegaserod Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171457


Locations
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00171457     History of Changes
Other Study ID Numbers: CHTF919DUS45
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: October 10, 2007
Last Verified: October 2007

Keywords provided by Novartis:
functional heartburn
dyspepsia
male
female
visceral sensitivity

Additional relevant MeSH terms:
Hypersensitivity
Dyspepsia
Heartburn
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs