The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
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.
Status: Completed (Phase 3). Started on April 1st, 2005. Ended on August 1st, 2006.
Enrollment: 60 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Double-Blind
- Placebo Control
- Parallel Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Drug: Tegaserod
Eligibility
Inclusion Criteria:
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 Criteria:
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.
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
N/A
Resources
Source: Novartis
Authority: United States: Food and Drug Administration
Locations
-
http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go
East Hanover
New Jersey
07936
United States
Officials
Novartis (Study Director, Novartis)
Sponsors
Novartis (Lead Sponsor)
References
None.
Links
- Date Verified
- January 1st, 2008
- First Received
- January 31st, 2008
- Last Changed
- January 31st, 2008
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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