Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Average severity score during each week. []
- Percentage of days with satisfactory relief of dyspepsia during each week. []
- Weekly global assessment of change in dyspepsia condition. []
- Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. []
- Quality of life at end of treatment compared to baseline. []
- Safety and tolerability. []
Eligibility Criteria
Criteria
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/exclusion criteria may appl
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis | East Hanover | New Jersey | United States | 07936-108 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Novartis, Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHTF919D2301