|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 -2-receptor antagonist (H2RA), and the effect of instituting rabeprazole therapy after failure to control nocturnal heartburn symptoms with other acid suppressive therapy. This is a multicentre, randomised (study medication is assigned by chance), controlled, parallel-group, open-label study in GERD patients. Patients will be screened and enter a 2-week run-in phase to document heartburn symptoms while on their current therapy, during which they will complete a daily diary of symptoms and antacid use. Patients who have troublesome nocturnal heartburn episodes, but adequate daytime heartburn symptom control (as defined) will enter an 8-week treatment phase where they are randomised to one of the rabeprazole regimens: 20mg once daily in the evening (dose administered 30minutes prior to the evening meal; "QPM" regimen), 10mg twice daily (dose administered 30minutes prior to the morning and evening meals; "BID/twice daily" regimen) or 20mg once daily in the morning (dose administered 30minutes prior to the morning meal; "QAM/every morning" regimen), plus antacids as required. The study hypothesis is that after failure to control night-time heartburn symptoms with other acid suppressive therapy, instituting rabeprazole will have a beneficial effect. Safety assessments include: physical examination and pregnancy test at screening, vital signs and weight at randomization and final visit, adverse event and concomitant medication reporting at every visit.
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:
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 |
|
day-time heartburn nocturnal heartburn rabeprazole GERD |
|
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 |