Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.
Information source: Janssen-Ortho Inc., Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux; Heartburn
Intervention: rabeprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen-Ortho Inc., Canada Official(s) and/or principal investigator(s): Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada
Summary
The purpose of this study is to evaluate the effect of each of the rabeprazole treatment
regimens on nocturnal heartburn symptoms.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary analysis will be based on the mean nocturnal heartburn score observed after four weeks of drug administration for each of the three dosing regimens of rabeprazole.
Secondary outcome: Nocturnal heartburn score at end of treatment/ 8 weeks; HRQoL and productivity outcomes 4 & 8 wks; rescue meds usage & compliance with study meds over entire study; day-time heartburn score 4 & 8 wks.
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have had a minimum three-month history of symptomatic GERD, with
heartburn as the predominant symptom, and must report nocturnal heartburn symptoms
(i. e., heartburn symptoms experienced during the night-time period, between 2200 and
0600h)
- Patients must currently be taking a proton-pump inhibitor (PPI) or histamine-2
receptor antagonist (H2RA) at least four weeks prior to study admission
- Patients must be able to read, write and understand the language of the HRQOL and
productivity assessment instruments (PAGI-SYM, PAGI-QOL, WPAI-GH) i. e., English or
French
- Patients must have been at least 80% compliant with their current acid suppressive
therapy, and must have completed a minimum of 11 of 14 nocturnal heartburn ratings
during the run-in period (i. e. <=3 "missing" nocturnal heartburn ratings during the
14-day period)
- Patients must have a total nocturnal heartburn symptom score of >4 points during the
2-week run-in period
- 3 "missing" nocturnal heartburn ratings during the 14-day period) as recorded in the
diary
- Night-time heartburn control assessment of "very dissatisfied, dissatisfied, neither
dissatisfied nor satisfied" at the end of the 2-week run-in period.
Exclusion Criteria:
- Patients currently taking rabeprazole 20mg once daily (morning or evening
administration) or 10mg twice daily (morning and evening administration) on a
continuous basis
- Documented evidence of GERD refractory to acid suppressive therapy (i. e.
- no or poor clinical response to at least two treatment courses of 4-weeks duration
with a PPI)
- Esophagitis known to be the result of systemic events (e. g. scleroderma, ingested
irritants)
- Active GI bleeding, or presence of "alarm symptoms" (i. e., vomiting, blood in stool,
anemia, dysphagia)
- Documented history of significant pyloric stenosis or esophageal ring stricture
- Documented evidence of esophageal or gastric varices
- Patients with primary motility disorders, infectious or inflammatory conditions of
the small or large intestine, malabsorption syndromes, GI obstruction, history of
gastrointestinal malignancy, definitive acid-lowering surgery or other esophageal,
gastric or intestinal surgery (including vagotomy) except for simple closure of
perforation
- Patients who are unable or unwilling to discontinue the use of prostaglandins (e. g.
misoprostol), sucralfate, prokinetic agents (e. g. 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
- Treatment with high-dose systemic corticosteroids (>10mg/day prednisone equivalent)
and NSAIDs, including COX-2 selective inhibitors, cannot be initiated at anytime
during the study. However, patients taking corticosteroids and NSAIDs (including ASA)
before study entry may continue these medications during the study, however, they
must have been taking a stable dose (e. g. for oral medication, a consistent daily
dose ± 25%) for at least 2 weeks before study admission and the dosage must be kept
constant throughout the study. Occasional, intermittent use of NSAIDs for acute,
self-limiting conditions (e. g. headache relief) is acceptable during the study
- >3 daytime episodes during any 7 consecutive days of the run-in period
- >1 severe or very severe daytime episode (i. e., more than 1 daytime heartburn episode
rated >=3) during any 7 consecutive days of the run-in period
- Maximum total daytime heartburn score >5 during any 7 consecutive days of the run-in
period.
Locations and Contacts
Additional Information
A randomized, controlled, parallel-group, open-label study to evaluate different dosing regimens of rabeprazole in controlling nocturnal heartburn symptoms in patients with gastroesophageal reflux disease
Starting date: July 2004
Last updated: May 16, 2011
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