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| Sponsored by: |
Janssen-Ortho Inc., Canada |
|---|---|
| Information provided by: | Janssen-Ortho Inc., Canada |
| ClinicalTrials.gov Identifier: | NCT00553449 |
Purpose
The purpose of this study is to evaluate the effect of each of the rabeprazole treatment regimens on nocturnal heartburn symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Heartburn |
Drug: rabeprazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised, Controlled, Parallel-Group, Open-Label Study to Evaluate Different Dosing Regimens of Rabeprazole in Controlling Nocturnal Heartburn Symptoms in Patients With Gastroesophageal Reflux Disease. |
| Estimated Enrollment: | 190 |
| Study Start Date: | July 2004 |
| Study Completion Date: | September 2005 |
There is limited data regarding the estimate of patients who experience nocturnal symptoms despite adequate daytime heartburn control, the incidence and severity of nocturnal heartburn episodes after a minimum of 4 weeks of acid suppressive therapy with a Proton-pump inhibitor (PPI) or Histamine
Rabeprazole 20mg once daily in the evening: one rabeprazole 20mg tablet daily in the evening, 30-60 minutes before dinner for 56 days OR Rabeprazole 10mg twice daily: one rabeprazole 10mg tablet in the morning, 30-60 minutes before breakfast, and one rabeprazole 10mg tablet 30-60 minutes before dinner for 56 days. OR Rabeprazole 20mg once daily in the morning: one rabeprazole 20mg tablet daily in the morning, 30-60 minutes before breakfast for 56 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
metoclopramide), anticholinergics, cholinergic agents or spasmolytics. Use of opiates may be continued if started at least 2 weeks before study admission and the dosage is consistent (± 25% for total opioid daily dose) throughout the study
Contacts and Locations
More Information
| Study ID Numbers: | CR005692 |
| Study First Received: | November 1, 2007 |
| Last Updated: | June 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00553449 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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day-time heartburn nocturnal heartburn rabeprazole GERD |
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Deglutition Disorders Esophageal Motility Disorders Signs and Symptoms Pyrosis Digestive System Diseases Signs and Symptoms, Digestive |
Esophageal Disorder Gastrointestinal Diseases Heartburn Esophageal Diseases Gastroesophageal Reflux Rabeprazole |
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Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders |
Deglutition Disorders Signs and Symptoms Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Heartburn Esophageal Diseases Rabeprazole |