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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171457
First received: September 12, 2005
Last updated: October 9, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

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 Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

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

ClinicalTrials.gov processed this record on May 19, 2013