- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171483
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).
January 24, 2008 updated by: Novartis
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Boynton Beach, Florida, United States, 33426
- Consultants for Clinical Research of South Florida
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Miami, Florida, United States, 33173
- Miami Research Associates
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Pembroke Pines, Florida, United States, 33024
- University Clinical Research
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North Carolina
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Winston Salem, North Carolina, United States, 27157
- Department of Internal Medicine - Wake Forest University School of Medicine
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Ohio
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Cincinnati, Ohio, United States, 45219
- Consultants for Clinical Research
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Virginia
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Fairfax, Virginia, United States, 22031
- Metropolitan Research
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Wisconsin
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Milwaukee, Wisconsin, United States, 53207
- The Wisconsin Center for Advanced Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
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Secondary Outcome Measures
Outcome Measure |
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To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
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To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
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To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
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To assess patient satisfaction with treatment (end of treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
January 28, 2008
Last Update Submitted That Met QC Criteria
January 24, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin Receptor Agonists
- Tegaserod
Other Study ID Numbers
- CHTF919BUS30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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