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 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...
Brief Summary
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 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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tegaserod
Outcome Measures for this Clinical Trial
Primary 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 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171418
Study ID Number: CHTF919BUS26
ClinicalTrials.gov Identifier: NCT00171418
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171418
