A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

Phase 2

Completed

• Conditions: Symptomatic Gastroespohageal Reflux Disease

• Registration Number: NCT00149851
• Lead Sponsor: Novartis

Brief Summary

Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2008-01
• Last Update Submitted: 2010-08-31
• Last Update Posted: 2010-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

Inclusion Criteria

• History of physician diagnosed GERD
• Heartburn and Regurgitation 3 Days during the week prior to screening

Exclusion Criteria

• History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
• History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
• Use of PPI during the last four weeks prior to screening

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
Decreasing frequency of regurgitation during week 4 of treatment
Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States