Back to resultsAssessment 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).
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, heartburn, regurgitation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Consultants for Clinical Research of South Florida
- Miami Research Associates
- University Clinical Research
- Department of Internal Medicine - Wake Forest University School of Medicine
- Consultants for Clinical Research
- Metropolitan Research
- The Wisconsin Center for Advanced Research
Outcomes
Primary Outcome Measures
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171483
Brief Title
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).
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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 .
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, heartburn, regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
Secondary Outcome Measure Information:
Title
To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
Title
To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Title
To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
Title
To assess patient satisfaction with treatment (end of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Consultants for Clinical Research of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
University Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Department of Internal Medicine - Wake Forest University School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
The Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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).
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