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 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
1296 Patients enrolled
Trial Details
Trial ID
NCT00232089
Start Date
May 1 2004
End Date
June 1 2006
Last Update
November 18 2016
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936-108