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NCT00171470 Clinical Trial

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

Dyspepsia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171470
Other study ID # CHTF919DUS46
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 31, 2008
Start date April 2005
Est. completion date August 2006

Study information
Verified date January 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tegaserod

Locations
Country Name City State
United States http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary Quality of Life (weekly assessment)
Secondary Safety and tolerability
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