Official Title: “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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

• Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
• Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
• Decreasing frequency of regurgitation during week 4 of treatment
• Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

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, 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair East Hanover NJ  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149851

Study ID Number: CHTF919B2203

ClinicalTrials.gov Identifier: NCT00149851

Health Authority: United States: Food and Drug Administration