Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Status and phase
Completed
Phase 3
Conditions
Gastroesophageal Reflux Disease (GERD)
Treatments
Drug: Tegaserod
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
2
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems