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)

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Novartis

Status and phase

Completed
Phase 2

Conditions

Symptomatic Gastroespohageal Reflux Disease

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00149851
CHTF919B2203

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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