Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Phase 3
Completed
- Conditions
- Dyspepsia
- Registration Number
- NCT00232089
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1296
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/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Weekly global assessment of change in dyspepsia condition. Weekly assessment of satisfactory relief of dyspepsia. Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. Safety and tolerability. For each week assessment of average daily severity score. Quality of life at end of treatment compared to baseline. Daily assessment of percentage of patients responding on average severity score. Percentage of days with satisfactory relief of dyspepsia during each week.
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States