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).
1 other identifier
interventional
30
1 country
7
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2004
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedJanuary 28, 2008
January 1, 2008
September 12, 2005
January 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
Secondary Outcomes (4)
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)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (7)
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426, United States
Miami Research Associates
Miami, Florida, 33173, United States
University Clinical Research
Pembroke Pines, Florida, 33024, United States
Department of Internal Medicine - Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
The Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
January 1, 2004
Study Completion
April 1, 2005
Last Updated
January 28, 2008
Record last verified: 2008-01