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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171418
• Other study ID #: CHTF919BUS26
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2008
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Drug Research Services, Inc	Metairie	Louisiana
United States	The Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Secondary	Safety assessment