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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171418
First received: September 12, 2005
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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 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: 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:


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

Estimated Enrollment: 54
Study Start Date: June 2003
Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171418

Locations
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
Study Director: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00171418     History of Changes
Other Study ID Numbers: CHTF919BUS26
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

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 October 01, 2014