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)
Completed · Phase 2
Conditions studied: Symptomatic Gastroespohageal Reflux Disease
In brief
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 to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.
Key facts
- Study ID
- NCT00149851
- Run by
- Novartis
- People needed
- 832
- Starts
- 2004-01-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2010-09-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of physician diagnosed GERD
- Heartburn and Regurgitation 3 Days during the week prior to screening
You may not qualify if…
- 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.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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