Status:
COMPLETED
A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)
Lead Sponsor:
Novartis
Conditions:
Symptomatic Gastroespohageal Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage...
Eligibility Criteria
Inclusion
- History of physician diagnosed GERD
- Heartburn and Regurgitation 3 Days during the week prior to screening
Exclusion
- History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
- History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
- Use of PPI during the last four weeks prior to screening
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT00149851
Start Date
January 1 2004
End Date
June 1 2005
Last Update
September 1 2010
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108