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OpenTrials
Completed

NCT Number: NCT00171457

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

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

Completed

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Key information

Conditions

Heartburn Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tegaserod

Drug

Primary outcomes

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

Secondary outcomes

  1. 1) Comparing effects at end of treatment compared to baseline:

  2. To verify that tegaserod modulates esophageal sensitivity to esophageal distention

  3. To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort

  4. To determine if tegaserod improves heartburn and/or regurgitation

  5. To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo

  6. Safety assessment

  7. To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Oct 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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