The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Status: Completed (Phase 3). Started on April 1st, 2005. Ended on September 1st, 2006.
Enrollment: 24 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Double-Blind
- Placebo Control
- Crossover Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Drug: Tegaserod
Eligibility
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.
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
N/A
Resources
Source: Novartis
Authority: United States: Food and Drug Administration
Locations
-
Oklahoma Foundation for Digestive Research
Oklahoma City
Oklahoma
73104
United States
Officials
Novartis (Study Director, Novartis)
Sponsors
Novartis (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- October 1st, 2007
- First Received
- October 9th, 2007
- Last Changed
- October 9th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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