Status:
COMPLETED
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).
Lead Sponsor:
Novartis
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 .
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00171483
Start Date
January 1 2004
End Date
April 1 2005
Last Update
January 28 2008
Active Locations (7)
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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