Symptomatic Gastroespohageal Reflux Disease
Conditions
Keywords
GERD, heartburn, regurgitation, reflux disease
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 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.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed