A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients. - NCT00787891-32601 (Clinical Trial 251850)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy251850.aspx
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| City: |
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Gainesville |
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State:
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FL |
| Zip Code: |
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32601 |
| Conditions: |
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GERD - Gastroesophageal Reflux Disease |
| Purpose: |
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The purpose of the study is to access the effectiveness and safety of oral rabeprazole in
the treatment of acid-related disorders in pediatric patients, focusing specifically on the
manifestation of GERD (symptomatic and erosive types).
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| Study summary: |
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This is a randomized, double-blind study that consists of two parts. In Part 1, the study
will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12
weeks comparing two doses of study drug (0.5 mg/kg or 1.0 mg/kg groups based on patient's
body weight), and an end-of-study or early withdrawal phase followed by Part 2, which
consists a of double-blind treatment continuation for patients who have achieved healing
during the short-term double-blind treatment phase. The double-blind maintenance treatment
phase lasts for not more than 24 weeks and is concluded by an end-of-study/early withdrawal
visit. During Part 1, patients will be screened and the diagnosis of erosive and non-erosive
GERD will be made based on clinical symptoms and confirmed by endoscopy/histology after a
biopsy. Patients enrolled in the study will receive study drug once daily for 12 weeks. Each
day, the parent/caregiver will record the presence and severity of pre-specified GERD
symptoms. At Weeks 4 and 8, the investigator will evaluate the response to treatment by
assessment of the GERD symptoms. At Week 12, the investigator will perform an endoscopy of
the esophagus with a biopsy to confirm that histological healing has occurred. If a patient
continues, additional study drug will be dispensed (at the same dose taken during the
short-term double-blind treatment phase) and the patient will be scheduled to return every 8
weeks until study drug is discontinued at Week 24 (Part 2) of the double-blind maintenance
treatment phase. At the final visit of the maintenance treatment phase Week 24 (Part 2),
assessments including an endoscopy of the esophagus with a biopsy be performed for each
patient. Assessments of effectiveness include endoscopic and histological grading of biopsy
samples, GERD symptom and severity score (symptoms and severity rated daily by the
parent/caregiver in an electronic diary), overall GERD symptom relief, Clinical Global
Impression of Improvement (CGI-I) score, and the Global Treatment Satisfaction Score. Safety
assessments will include the monitoring of concomitant therapies and adverse events
throughout the study, clinical laboratory testing (including hematology, clinical chemistry,
urinalysis), vital signs, and physical examination including height, weight, and Tanner
staging.
Oral rabeprazole 2.5 capsules or 5 mg capsules, given once daily at a dose of 0.5 mg/kg or
1.0 mg/kg; short-term treatment phase is 12 weeks; long-term maintenance treatment phase is
24 weeks. |
| Criteria: |
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Inclusion Criteria:
- History of at least 1 GERD symptom within 3 months of screening
- Positive esophagogastroduodenoscopy
- Signed informed consent
- Female patients (if menstruating) must be practicing birth control
Exclusion Criteria:
- Patients with history of esophagitis
- Patients who have milk protein allergy
- Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
- Patients who have taken sucralate or any medication that affects gastrointestinal
motility
- Patients with H. pylori
- Patients with lab values outside the normal age appropriate range
- Patients who have participated in another trial within 30 days before screening
- Patients with allergies to Proton Pump Inhibitors |
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| Study is available at: |
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Gainesville, FL 32601
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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