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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171470

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia	Drug: Tegaserod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment) []

Secondary Outcome Measures

Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment) []
Quality of Life (weekly assessment) []
Safety and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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.