Status:
COMPLETED
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Lead Sponsor:
Novartis
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.
Eligibility Criteria
Inclusion
- GERD symptoms for at least 6 months
- PPI therapy for at least 4 weeks
- Incomplete symptom relief on daily PPI therapy
- No erosive disease as evidenced in EGD/no change in symptom severity
Exclusion
- Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
- Previous gastrointestinal surgery that may influence esophageal motor function
- Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
- Evidence of cathartic colon or a history of laxative use
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00171418
Start Date
June 1 2003
End Date
February 1 2005
Last Update
January 28 2008
Active Locations (2)
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1
Drug Research Services, Inc
Metairie, Louisiana, United States, 70001
2
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104