Back to resultsAssessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring GERD, PPI
Eligibility Criteria
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.
Sites / Locations
- Drug Research Services, Inc
- The Oklahoma Foundation for Digestive Research
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171418
Brief Title
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Official Title
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
GERD, PPI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Title
Safety assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Drug Research Services, Inc
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
The Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
We'll reach out to this number within 24 hrs