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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00171418
• Collaborator: (none)
• Enrollment: 54
• Locations: 2
• Duration (Months): 20.1
• Patients Per Site: 27
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jun 1, 2003
• Actual Study Completion Date: Feb 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Drug Research Services, Inc	Metairie	Louisiana	United States	70001
2	The Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00171418
• Other Study ID Numbers: CHTF919BUS26
• First Posted: Sep 15, 2005
• Last Update Posted: Jan 28, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: GERD; PPI
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Tegaserod

Study Results

No Results Posted as of Jan 28, 2008