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 patients, 18 years and 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 esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline. * Current or history of erosive esophagitis confirmed by EGD * Heartburn occurring 3 or more days a week. 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 postprandial fullness early satiety and bloating) | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily assessment of percentage of patients responding on average severity score. | — |
| For each week assessment of average daily severity score. | — |
| Percentage of days with satisfactory relief of dyspepsia during each week. | — |
| Weekly assessment of satisfactory relief of dyspepsia. | — |
| Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. | — |
| Quality of life at end of treatment compared to baseline. | — |
| Safety and tolerability. | — |
| Weekly global assessment of change in dyspepsia condition. | — |
Countries
United States
Outcome results
None listed