Dyspepsia
Conditions
Keywords
Dyspepsia, gastrointestinal, tegaserod
Brief summary
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
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, 18 years or older * Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia for at least 12 weeks, not necessarily consecutive, during the previous 12 months.
Exclusion criteria
* Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions. * Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of days with satisfactory relief of dyspepsia during each week. | — |
| Weekly global assessment of change in dyspepsia condition. | — |
| Average severity score during each week. | — |
| Quality of life at end of treatment compared to baseline. | — |
| Safety and tolerability. | — |
| Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. | — |
Countries
United States
Outcome results
None listed