Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: January 24, 2008
Last verified: January 2008
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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).|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
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
|Study Start Date:||June 2003|
|Study Completion Date:||February 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171418
|United States, Louisiana|
|Drug Research Services, Inc|
|Metairie, Louisiana, United States, 70001|
|United States, Oklahoma|
|The Oklahoma Foundation for Digestive Research|
|Oklahoma City, Oklahoma, United States, 73104|
Sponsors and Collaborators