Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171483

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Tegaserod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment) []

Secondary Outcome Measures

To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline) []
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments) []
To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients []
To assess patient satisfaction with treatment (end of treatment) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Heartburn for at least 3 days in the week prior to screening
Regurgitation for at least 3 days in the week prior to screening
Stable dose PPI therapy > 4 weeks
Incomplete relief on daily PPI therapy > 4 weeks

Exclusion Criteria:

Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
Previous gastrointestinal surgery that may influence esophageal motor function
Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consultants for Clinical Research of South Florida	Boynton Beach	Florida	United States	33426
2	Miami Research Associates	Miami	Florida	United States	33173
3	University Clinical Research	Pembroke Pines	Florida	United States	33024
4	Department of Internal Medicine - Wake Forest University School of Medicine	Winston Salem	North Carolina	United States	27157
5	Consultants for Clinical Research	Cincinnati	Ohio	United States	45219
6	Metropolitan Research	Fairfax	Virginia	United States	22031
7	The Wisconsin Center for Advanced Research	Milwaukee	Wisconsin	United States	53207