Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
GERD, PPI, heartburn, regurgitation
Brief summary
Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .
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
* Heartburn for at least 3 days in the week prior to screening * Regurgitation for at least 3 days in the week prior to screening * Stable dose PPI therapy \> 4 weeks * Incomplete relief on daily PPI therapy \> 4 weeks
Exclusion criteria
* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions * Previous gastrointestinal surgery that may influence esophageal motor function * Evidence of cathartic colon or a history of laxative use Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline) | — |
| To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments) | — |
| To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients | — |
| To assess patient satisfaction with treatment (end of treatment) | — |
Countries
United States
Outcome results
None listed