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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
History of Changes

September 6, 2005
August 31, 2010
January 2004
June 2005   (final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00149851 on ClinicalTrials.gov Archive Site
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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)
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)

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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Symptomatic Gastroespohageal Reflux Disease
Drug: Tegaserod
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
832
June 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149851
CHTF919B2203
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Novartis
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Study Chair: Novartis East Hanover NJ
Novartis
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP