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).

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171483
• Other study ID #: CHTF919BUS30
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2008
• Start date: January 2004
• Est. completion date: April 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 tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2005
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Consultants for Clinical Research of South Florida	Boynton Beach	Florida
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Metropolitan Research	Fairfax	Virginia
United States	Miami Research Associates	Miami	Florida
United States	The Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	University Clinical Research	Pembroke Pines	Florida
United States	Department of Internal Medicine - Wake Forest University School of Medicine	Winston Salem	North Carolina

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 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
Secondary	To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
Secondary	To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
Secondary	To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
Secondary	To assess patient satisfaction with treatment (end of treatment)