Status:
COMPLETED
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
Lead Sponsor:
Novartis
Conditions:
Dyspepsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.
Eligibility Criteria
Inclusion
- Female patients 18 years or older.
- Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
- Stable dose PPI therapy of at least 4 weeks
Exclusion
- History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
- Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
- With a current most bothersome symptom of heartburn.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00171470
Start Date
April 1 2005
End Date
August 1 2006
Last Update
February 1 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go
East Hanover, New Jersey, United States, 07936