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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00992589




Trial ID
NCT00992589
Ethics application status
Date submitted
4/09/2009
Date registered
8/10/2009
Date last updated
16/04/2013

Titles & IDs
Public title
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Scientific title
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD)
Secondary ID [1] 0 0
RABGRD3004
Secondary ID [2] 0 0
CR014836
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rabeprazole sodium 5 mg
Treatment: Drugs - Rabeprazole sodium 10 mg
Treatment: Drugs - Placebo

Experimental: Rabeprazole sodium 5 mg -

Experimental: Rabeprazole sodium 10 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: Rabeprazole sodium 5 mg
Rabeprazole Sodium 5 mg capsules once daily in the morning.

Treatment: Drugs: Rabeprazole sodium 10 mg
Rabeprazole Sodium 10 mg capsules once daily in the morning.

Treatment: Drugs: Placebo
Matching placebo capsules once daily in the morning.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
Timepoint [1] 0 0
Baseline, Week 8
Primary outcome [2] 0 0
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward) - Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant's age and gender (Borghi E, 2006).
Timepoint [2] 0 0
Baseline, Week 8
Primary outcome [3] 0 0
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward) - The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.
Timepoint [3] 0 0
Baseline, Week 8
Primary outcome [4] 0 0
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward) - The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.
Timepoint [4] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward) - The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.
Timepoint [2] 0 0
Baseline, Week 8
Secondary outcome [3] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward) - The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.
Timepoint [3] 0 0
Baseline, Week 8
Secondary outcome [4] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward) - The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.
Timepoint [4] 0 0
Baseline, Week 8

Eligibility
Key inclusion criteria
- Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically
proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the
following: a) poor weight gain, or b) irritability, excessive crying or disturbed
sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)

- or c) refusal to eat even if hungry or arching of the back during meals

- weight 2.5 kg to 15.0 kg

- I-GERQ-R score >16

- Have only 1 caregiver in addition to the parent(s)
Minimum age
1 Month
Maximum age
11 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of confirmed acute life-threatening events due to GERD

- Known narrowing of the opening from the stomach to the small intestines

- Confirmed diagnosis of cow's milk allergy

- Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production)
or any of several drugs that affect the normal movement of the digestive tract
(caffeine, theophylline, antacids, erythromycin, and others) within 3 days before
entering the study

- Have blood or urine test results that are well above or below the normal range for the
infant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Gyulai Ut 18
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Szombathely
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tiberias
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Netherlands
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Amsterdam
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Nijmegen
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Zwolle
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Bialystok
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Durban
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Panorama
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Wynberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an
inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with
placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to
11 months of age.
Trial website
https://clinicaltrials.gov/show/NCT00992589
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries