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)

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00149851
• Collaborator: (none)
• Enrollment: 832
• Location: 1
• Duration (Months): 17
• Patients Per Site Per Month: 49

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Gastroespohageal Reflux Disease	Drug: Tegaserod	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Proportion of patients experiencing resolution of heart-burn during week 4 of treatment []

2. Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone []

3. Decreasing frequency of regurgitation during week 4 of treatment []

4. Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis	East Hanover	New Jersey	United States	07936-108

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, East Hanover NJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00149851
• Other Study ID Numbers: CHTF919B2203
• First Posted: Sep 8, 2005
• Last Update Posted: Sep 1, 2010
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: GERD, heartburn, regurgitation, reflux disease
• Additional relevant MeSH terms: Gastroesophageal Reflux; Tegaserod

Study Results

No Results Posted as of Sep 1, 2010