Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
GERD, PPI
Brief summary
Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* GERD symptoms for at least 6 months * PPI therapy for at least 4 weeks * Incomplete symptom relief on daily PPI therapy * No erosive disease as evidenced in EGD/no change in symptom severity
Exclusion criteria
* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions * Previous gastrointestinal surgery that may influence esophageal motor function * Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder * 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 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline) | — |
| To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments) | — |
| Safety assessment | — |
Countries
United States
Outcome results
None listed