Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
1 other identifier
interventional
54
1 country
2
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.
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 Jun 2003
2 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
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 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 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.
Secondary Outcomes (3)
To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Safety assessment
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
- Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
- Evidence of cathartic colon or a history of laxative use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Drug Research Services, Inc
Metairie, Louisiana, 70001, United States
The Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
June 1, 2003
Study Completion
February 1, 2005
Last Updated
January 28, 2008
Record last verified: 2008-01