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.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171418

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 III

MedlinePlus related topics: GERD

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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).

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

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

More Information

Study ID Numbers:	CHTF919BUS26
Study First Received:	September 12, 2005
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00171418
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

GERD
PPI

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Esophageal Diseases
Gastroesophageal Reflux
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009