Dyspepsia
Conditions
Keywords
dyspepsia, hearburn, female, PPI
Brief summary
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Female patients 18 years or older. * Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating) * Stable dose PPI therapy of at least 4 weeks
Exclusion criteria
* History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions. * Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form. * With a current most bothersome symptom of heartburn. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment) | — |
| Quality of Life (weekly assessment) | — |
| Safety and tolerability | — |
Countries
United States
Outcome results
None listed