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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).

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171483
First Posted: September 15, 2005
Last Update Posted: January 28, 2008
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.
Information provided by:
Novartis
  Purpose
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 .

Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD) Drug: Tegaserod Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Novartis:

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)

Estimated Enrollment: 30
Study Start Date: January 2004
Study Completion Date: April 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
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): NCT00171483


Locations
United States, Florida
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States, 33426
Miami Research Associates
Miami, Florida, United States, 33173
University Clinical Research
Pembroke Pines, Florida, United States, 33024
United States, North Carolina
Department of Internal Medicine - Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
United States, Wisconsin
The Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53207
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00171483     History of Changes
Other Study ID Numbers: CHTF919BUS30
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: January 28, 2008
Last Verified: January 2008

Keywords provided by Novartis:
GERD
PPI
heartburn
regurgitation

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Tegaserod
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs