Gastroesophageal Reflux DiseasePhase 2NCT00132496
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
A Phase 2 study testing rabeprazole sodium in people with Gastroesophageal Reflux Disease, run by Eisai Inc. at 25 sites in United States.
Trial summary
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- How many people
- 111 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 2005to Jul 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD.
- Patients who have ever been treated with, or are currently receiving proton pump inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long as they can go off PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing; exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for two weeks at the end active drug treatment.
- Children with stable asthma/reactive airways disease on stable treatment regimens are eligible.
- Children on stable doses of allergy, antiepileptic, antidepressant, and attention deficit disorder medicines are eligible.
- Patients must be able and willing to swallow the test drug tablet intact. The ability of the child to swallow an intact tablet must be confirmed by the site at Screening.
- The patient is willing and able to give assent to participate.
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- The patient's parent or guardian gives written informed consent.
- Post-pubertal females will be required to be abstinent during the course of the study.
- Clinically insignificant laboratory findings.
Who cannot join
- Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- History of primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections).
- History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy. History or current presence of peptic ulcers; current presence of Helicobacter pylori.
- History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture is disallowed. History of fundoplication or feeding tube insertion is allowed.
- Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor), except for cimetidine, which must be discontinued for at least seven days prior to dosing.
- Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor).
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- Inability to have 2-week PPI therapy-free period at end of active drug treatment.
- Pregnancy or lactation.
- Known or suspected drug addiction or alcohol abuse and/or a positive urine drug screen not explained by medication list; occasional alcohol or tobacco use is not an exclusion criterion.
- Unwilling or unable to abide by the requirements of the study or violating the prohibitions and restrictions of the study defined in Section 9.4.
- Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study.
- Participation in another investigational drug study within one month prior to dosing.
- A history of allergy/sensitivity to proton pump inhibitors or to their inactive ingredients.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Children's Hospital of Buffalo - Digestive Disease And Nutrition Center
Buffalo, New York, 14222
Professional Clinical Research
Cadillac, Michigan, 49601
Pediatric Associates of Mount Carmel, Inc.
Cincinnati, Ohio, 45245
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, 45245
Nova Southeastern University
Fort Lauderdale, Florida, 33328
DeGarmo Institute of Medicine Research
Greer, South Carolina, 29651
Focus Research Group
Hendersonville, Tennessee, 37075
Multi-specialty Clinical Research
Hoffman Estates, Illinois, 60194
Marshall University
Huntington, West Virginia, 25701
ProMed Healthcare
Johnson City, Tennessee, 37601
Community Pediatric Associates
Kalamazoo, Michigan, 49008
NE Ohio University College of Medicine
Lebanon, Tennessee, 37087
Longmont Medical Research Network
Longmont, Colorado, 80501
University of Pediatrics
Mason, Ohio, 45040
Winthrop University Hospital
Mineola, New York, 11501
Babies and Beyond Peds
New Port Richey, Florida, 34652
The Center for Human Nutrition
Omaha, Nebraska, 68105
Alpine Medical Group
Salt Lake City, Utah, 84102
Southwest Children's Research Associates
San Antonio, Texas, 78229
Biomedical Research Associates
Shippensburg, Pennsylvania, 17257
Dr. Patricia Barrington, Dr. B. Abraham, PC
Snellville, Georgia, 30039
Rockwood Clinic North
Spokane, Washington, 99202
Center for Children's Digestive Health
Youngstown, Ohio, 44514
Pharmacotherapy Research Associates
Zanesville, Ohio, 43701
About this study
Official title: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- rabeprazole sodium
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole sodiumDrug
administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.
Measured: 8 weeks from randomization and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yufang Lu, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132496
- Sponsor's protocol ID
- E3810-A001-202
- Status last verified
- Nov 2009
- First submitted
- 19 Aug 2005
- Last updated
- 3 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
- ClinicalTrials.gov ID
- NCT00132496
- Acronym / sponsor ID
- E3810-A001-202
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Posted 3 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD.
- Patients who have ever been treated with, or are currently receiving proton pump inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long as they can go off PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing; exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for two weeks at the end active drug treatment.
- Children with stable asthma/reactive airways disease on stable treatment regimens are eligible.
- Children on stable doses of allergy, antiepileptic, antidepressant, and attention deficit disorder medicines are eligible.
- Patients must be able and willing to swallow the test drug tablet intact. The ability of the child to swallow an intact tablet must be confirmed by the site at Screening.
Key exclusion criteria (13 listed)
- Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- History of primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections).
- History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy. History or current presence of peptic ulcers; current presence of Helicobacter pylori.
- History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture is disallowed. History of fundoplication or feeding tube insertion is allowed.
- Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor), except for cimetidine, which must be discontinued for at least seven days prior to dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rabeprazole sodiumadministered orally and once daily to patients randomized to receive either 10 mg or 20 mg. | Drug | – |
Primary outcome
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Time frame: 8 weeks from randomization and end of treatment
Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yufang Lu study director
Eisai Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rabeprazole sodium in people with Gastroesophageal Reflux Disease, run by Eisai Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group (time frame: 8 weeks from randomization and end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.