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).

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)

• Registration Number: NCT00171483
• Lead Sponsor: Novartis

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study Completion: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-24
• Last Update Posted: 2008-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (7)

Consultants for Clinical Research of South Florida; 🇺🇸 Boynton Beach, Florida, United States

Department of Internal Medicine - Wake Forest University School of Medicine; 🇺🇸 Winston Salem, North Carolina, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

University Clinical Research; 🇺🇸 Pembroke Pines, Florida, United States

Consultants for Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Metropolitan Research; 🇺🇸 Fairfax, Virginia, United States

The Wisconsin Center for Advanced Research; 🇺🇸 Milwaukee, Wisconsin, United States