Status:
COMPLETED
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Lead Sponsor:
Novartis
Conditions:
Heartburn
Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00171457
Start Date
April 1 2005
End Date
September 1 2006
Last Update
October 10 2007
Active Locations (1)
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1
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104