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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149851
First received: September 6, 2005
Last updated: August 31, 2010
Last verified: January 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
Tegaserod maleate
U.S. FDA Resources
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 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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013