Gastroesophageal Reflux Disease (GERD)Phase 3NCT00787891
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
A Phase 3 study testing rabeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- rabeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 3
- 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 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months of screening
- Positive esophagogastroduodenoscopy
- Signed informed consent
- Female patients (if menstruating) must be practicing birth control
Who cannot join
- 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
About this study
Official title: A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD
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).
Read the detailed description
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 Gastroesophageal Reflux Disease (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.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- rabeprazole
- Keywords
- Gastroesophageal Reflux Disease (GERD), Erosive Gastroesophageal Reflux Disease, Ulcerative Gastroesophageal Reflux Disease, Endoscopy, Pediatrics, Rabeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
rabeprazoleDrug
1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazole 0.5 mg/kg | Experimental | rabeprazole 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks Receives: Drug: rabeprazole |
| Rabeprazole 1.0 mg/kg | Experimental | rabeprazole 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks Receives: Drug: rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
Measured: 12 weeks
The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
Measured: 36 weeks
Secondary outcomes (4)
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)
The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.
Measured: Baseline, Week 12
The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)
The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.
Measured: Baseline, Week 12
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)
The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.
Measured: Baseline, Week 36
The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)
The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.
Measured: Baseline, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787891
- Sponsor's protocol ID
- CR014833
- Other IDs
- RABGRD3003
- Status last verified
- Jan 2013
- First submitted
- 6 Nov 2008
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Haddad I, Kierkus J, Tron E, Ulmer A, Hu P, Sloan S, Silber S, Leitz G. Efficacy and safety of rabeprazole in children (1-11 years) with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2013 Dec;57(6):798-807. doi: 10.1097/MPG.0b013e3182a4e718.
PubMed 23863328
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD
- ClinicalTrials.gov ID
- NCT00787891
- Acronym / sponsor ID
- CR014833
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease (GERD), Erosive Gastroesophageal Reflux Disease, Ulcerative Gastroesophageal Reflux Disease, Endoscopy, Pediatrics, Rabeprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Posted 11 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 Gastroesophageal Reflux Disease (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rabeprazole 0.5 mg/kg | Experimental | Drug: rabeprazolerabeprazole 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks |
| Rabeprazole 1.0 mg/kg | Experimental | Drug: rabeprazolerabeprazole 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months of screening
- Positive esophagogastroduodenoscopy
- Signed informed consent
- Female patients (if menstruating) must be practicing birth control
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| rabeprazole0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks | Drug | Rabeprazole 0.5 mg/kg |
| rabeprazole1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks | Drug | Rabeprazole 1.0 mg/kg |
Primary outcome
The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)
Time frame: 12 weeks
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)
Time frame: 36 weeks
Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.
4 secondary outcomes
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)
Time frame: Baseline, Week 12
The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)
Time frame: Baseline, Week 12
The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)
Time frame: Baseline, Week 36
The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)
Time frame: Baseline, Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23863328Haddad I, Kierkus J, Tron E, Ulmer A, Hu P, Sloan S, Silber S, Leitz G. Efficacy and safety of rabeprazole in children (1-11 years) with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2013 Dec;57(6):798-807. doi: 10.1097/MPG.0b013e3182a4e718.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rabeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 8 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Oct 2012). 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?
The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787891, which also lists 1 linked publication.
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 24 Jan 2013.