Symptomatic Gastroespohageal Reflux Disease Clinical Trial
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)
| Verified date | January 2008 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 832 |
| Est. completion date | June 2005 |
| Est. primary completion date | June 2005 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis | East Hanover | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients experiencing resolution of heart-burn during week 4 of treatment | |||
| Primary | Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone | |||
| Primary | Decreasing frequency of regurgitation during week 4 of treatment | |||
| Primary | Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone |