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Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00171418
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 28, 2008
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: Tegaserod Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : June 2003
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. 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 :
  1. 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)
  2. To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
  3. Safety assessment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171418


Locations
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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
Novartis
Investigators
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Study Director: Novartis Novartis
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ClinicalTrials.gov Identifier: NCT00171418    
Other Study ID Numbers: CHTF919BUS26
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2008
Keywords provided by Novartis:
GERD
PPI
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs