Status:
COMPLETED
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Lead Sponsor:
Novartis
Conditions:
Dyspepsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
1296 Patients enrolled
Trial Details
Trial ID
NCT00232024
Start Date
January 1 2004
End Date
May 1 2006
Last Update
February 1 2008
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108