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

Novartis

Status and phase: Completed; Phase 3

Conditions: Heartburn; Dyspepsia

Treatments: Drug: Tegaserod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171457

CHTF919DUS45

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind