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.

Condition	Intervention	Phase
symptomatic gastroespohageal reflux disease	Drug: Tegaserod	Phase II

Further Study Details: 

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• History of physician diagnosed GERD
• Heartburn and Regurgitation 3 Days during the week prior to screening

Exclusion Criteria:

• History of erosive esophagitis, Barrett’s esophagus, sophageal 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.

New Jersey
      Novartis, East Hanover,  New Jersey,  07936-108,  United States

Study chairs or principal investigators

Novartis,  Study Chair,  East Hanover NJ   

Study ID Numbers:  CHTF919B2203
Last Updated:  September 9, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149851
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13