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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171483
First received: September 12, 2005
Last updated: January 24, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00171483     History of Changes
Other Study ID Numbers: CHTF919BUS30
Study First Received: September 12, 2005
Last Updated: January 24, 2008
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013