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).

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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 .

Key facts

Study ID

NCT00171483

Run by

Novartis

People needed

30

Starts

2004-01-01

Expected to finish

2005-04-01

Last updated by the study team

2008-01-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• University Clinical Research — Pembroke Pines, Florida, United States
• Department of Internal Medicine - Wake Forest University School of Medicine — Winston-Salem, North Carolina, 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

Full record on ClinicalTrials.gov

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