The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Completed · Phase 3

Conditions studied: Dyspepsia

In brief

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.

Key facts

Study ID

NCT00171470

Run by

Novartis

People needed

60

Starts

2005-04-01

Expected to finish

2006-08-01

Last updated by the study team

2008-02-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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