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)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149851
First received: September 6, 2005
Last updated: August 31, 2010
Last verified: January 2008
  Purpose

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 Intervention Phase
Symptomatic Gastroespohageal Reflux Disease
Drug: Tegaserod
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 832
Study Start Date: January 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149851

Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936-108
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis East Hanover NJ
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149851     History of Changes
Other Study ID Numbers: CHTF919B2203
Study First Received: September 6, 2005
Last Updated: August 31, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
GERD, heartburn, regurgitation, reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Tegaserod
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014