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CompletedNCT00992589Updated May 22, 2013Results posted

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

A Phase 3 interventional study of Rabeprazole sodium 5 mg and Rabeprazole sodium 10 mg in Gastroesophageal Reflux, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 84 sites in 10 countries. Open to participants aged 1 Month to 11 Months. Per ClinicalTrials.gov, last updated 2013-05-22.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
1 Month to 11 Months
Sex
All
01

Study 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.

Read the detailed description

Rabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which suppress gastric acid secretion. The drug is approved in the United States for the treatment of adults with GERD and other acid-related gastrointestinal disorders, and has been studied in adolescents (older than 12 years of age) with results similar to those in adults. However, the drug has not been studied in children under the age of 12 years. This study focuses on the efficacy and safety of rabeprazole sodium in infants aged 1 to 11 months, the pediatric group in which the prevalence of GERD-related symptoms is the greatest. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group withdrawal study to compare the efficacy and safety of 2 doses (0.5 mg/kg or 1.0 mg/kg daily) of rabeprazole with placebo in the treatment of infants aged 1 to 11 months who have a diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD. The study consists of 3 study periods: a screening period of up to 10 days, an open-label treatment period of up to 3 weeks, and a 5-week double-blind treatment period. Patients who have been receiving GERD therapy before screening will have their GERD therapy discontinued for 3 days before entering the open-label treatment period. Patients who have a positive clinical response according to the Clinical Global Impressions - Improvement (CGI-I) scale at the end of the first or second week of the open-label treatment period will enter the double-blind treatment period; those who do not will be withdrawn from the study. A parent, legal guardian, or other individual experienced in the care of the infant will be the primary caregiver, who is responsible for the daily and weekly assessments and study drug administration. Efficacy assessments consist of the Infant Gastroesophageal Reflux Questionnaire Revised (I GERQ-R) total score, the Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I GERQ-DD) total score, the CGI-I, the Global Treatment Satisfaction Score, and the weight-for-age Z-score. Safety assessments include monitoring of concomitant therapies and adverse events throughout the study; clinical laboratory testing (hematology, clinical chemistry, urinalysis), measurement of vital signs (pulse and respiratory rate, blood pressure, temperature); and physical examination including length and weight. The study hypothesis is that rabeprazole sodium is superior to placebo in the treatment of GERD in infants aged 1 to 11 months. Rabeprazole sodium capsule(s) by mouth once a day, 10.0 milligram (mg)/kilogram (kg) for up to 3 weeks during the open-label treatment period and either 5.0 mg/kg or 10.0 mg/kg during the 5-week double-blind treatment period. To give the study drug to the infants, the contents of the capsule(s) are sprinkled onto a small amount of soft food or, as needed, the contents of the capsule(s) may be given in a small amount (5 milliliter [mL]) of infant formula or expressed breast milk.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • Gastroesophageal Reflux
  • Gastroesophageal Reflux Disease
  • GERD
  • Proton Pump Inhibitor
  • PPI
  • Regurgitation
  • Infants
  • AcipHex, PARIET
  • ALFENCE
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 344 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 11 Months
Sexes eligible
All
Accepts healthy volunteers
No

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)

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
344 participants (actual)

Study arms

  • Experimental
    Rabeprazole sodium 5 mg

    Drug: Rabeprazole sodium 5 mg

  • Experimental
    Rabeprazole sodium 10 mg

    Drug: Rabeprazole sodium 10 mg

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugRabeprazole sodium 5 mg

    Rabeprazole Sodium 5 mg capsules once daily in the morning.

  • DrugRabeprazole sodium 10 mg

    Rabeprazole Sodium 10 mg capsules once daily in the morning.

  • DrugPlacebo

    Matching placebo capsules once daily in the morning.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)

    Time frame: Baseline, Week 8

  2. 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).

    Time frame: Baseline, Week 8

  3. 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.

    Time frame: Baseline, Week 8

  4. 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.

    Time frame: Baseline, Week 8

Secondary outcomes

  1. The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period

    Time frame: Baseline, Week 8

  2. 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.

    Time frame: Baseline, Week 8

  3. 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.

    Time frame: Baseline, Week 8

  4. 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.

    Time frame: Baseline, Week 8

07

Results

Posted May 22, 2013

Participant flow

Open-Label Phase
Participant flow — Open-Label Phase
MilestoneOpen-Label Rabeprazole Sodium 10 mgDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mg
Started344000
Completed267000
Not completed77000
Withdrew: Adverse event4000
Withdrew: Withdrawal by subject20000
Withdrew: Lost to follow-up1000
Withdrew: Protocol violation3000
Withdrew: Physician decision4000
Withdrew: Other45000
Double-Blind Phase
Participant flow — Double-Blind Phase
MilestoneOpen-Label Rabeprazole Sodium 10 mgDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mg
Started0899088
Completed0767778
Not completed0131310
Withdrew: Adverse event0623
Withdrew: Withdrawal by subject0652
Withdrew: Lost to follow-up0002
Withdrew: Other0163

Outcome measures

PrimaryChange From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
Time frame:
Baseline, Week 8
Reported as:
Mean · frequency of Regurgitation
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
frequency of RegurgitationDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)-0.8 ± 1.58-0.8 ± 1.55-1.6 ± 3.63-1.2 ± 2.79
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.168 · Least-squares mean difference: -0.449 · 95% CI -1.087 to 0.190
PrimaryChange 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).

Time frame:
Baseline, Week 8
Reported as:
Mean · Z-score
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)
Z-scoreDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)0.11 ± 0.3290.16 ± 0.3220.11 ± 0.2640.14 ± 0.295
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.440 · Least-squares mean difference: 0.030 · 95% CI -0.047 to 0.108
SecondaryThe Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
Time frame:
Baseline, Week 8
Reported as:
Mean · number of episodes
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
number of episodesDouble-Blind Placebo - BaselineDouble-Blind Rabeprazole Sodium 5 mg - BaselineDouble-Blind Rabeprazole Sodium 10 mg - BaselineDouble-Blind Placebo - Week 8Double-Blind Rabeprazole Sodium 5 mg - Week 8Double-Blind Rabeprazole Sodium 10 mg - Week 8Double-Blind Rabeprazole Sodium Total - BaselineDouble-Blind Rabeprazole Sodium Total - Week 8
Less than 1 tablespoon1.2 ± 2.521.1 ± 1.491.9 ± 4.250.8 ± 2.150.7 ± 1.351.0 ± 1.921.5 ± 3.180.9 ± 1.66
1 to 2 tablespoons0.7 ± 1.040.7 ± 1.081.2 ± 1.730.5 ± 1.620.4 ± 0.750.7 ± 1.551.0 ± 1.450.6 ± 1.21
More than 2 tablespoons to 2 fluid oz0.3 ± 0.530.2 ± 0.430.3 ± 0.770.2 ± 0.480.1 ± 0.600.2 ± 0.650.2 ± 0.620.2 ± 0.63
More than 2 fluid oz to 4 fluid oz0.1 ± 0.190.0 ± 0.090.0 ± 0.080.0 ± 0.090.0 ± 0.140.0 ± 0.230.0 ± 0.080.0 ± 0.19
More than 4 fluid oz0.0 ± 0.050.0 ± 0.140.0 ± 0.240.0 ± 0.110.0 ± 0.050.0 ± 0.040.0 ± 0.200.0 ± 0.04
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
scores on a scaleDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)-0.8 ± 2.57-0.8 ± 2.56-1.0 ± 2.38-0.9 ± 2.47
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.984 · Least-squares mean difference: 0.006 · 95% CI -0.619 to 0.632
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
scores on a scaleDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)0.0 ± 2.24-0.1 ± 1.88-0.4 ± 1.94-0.2 ± 1.9
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.479 · Least-squares mean difference: -0.182 · 95% CI -0.690 to 0.325
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
scores on a scaleDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)-0.1 ± 2.54-0.1 ± 2.19-0.4 ± 2.15-0.3 ± 2.17
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.498 · Least-squares mean difference: -0.192 · 95% CI -0.751 to 0.366
PrimaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
scores on a scaleDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)-3.6 ± 6.41-3.8 ± 7.5-4.1 ± 7-3.9 ± 7.24
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.960 · Least-squares mean difference: 0.042 · 95% CI -1.615 to 1.700
PrimaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
scores on a scaleDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mgDouble-Blind Rabeprazole Sodium Total
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)-1.9 ± 4.55-1.6 ± 4.85-2.1 ± 4.9-1.9 ± 4.86
Statistical analysis
  • Double-Blind Placebo vs Double-Blind Rabeprazole Sodium Total · ANCOVA · p = 0.968 · Least-squares mean difference: 0.024 · 95% CI -1.167 to 1.214

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open-Label Rabeprazole Sodium 10 mg—15/344 (4.4%)116/344 (33.7%)
Double-Blind Placebo—2/89 (2.2%)33/89 (37.1%)
Double-Blind Rabeprazole Sodium 5 mg—8/90 (8.9%)34/90 (37.8%)
Double-Blind Rabeprazole Sodium 10 mg—3/88 (3.4%)32/88 (36.4%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventOpen-Label Rabeprazole Sodium 10 mgDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mg
GastroenteritisInfections and infestations2/3440/892/900/88
Upper Respiratory Tract InfectionInfections and infestations2/3440/892/900/88
Urinary Tract InfectionInfections and infestations2/3440/892/900/88
BronchiolitisInfections and infestations1/3440/890/901/88
Viral InfectionInfections and infestations1/3440/890/901/88
Beta 2 Microglobulin IncreasedInvestigations1/3440/890/901/88
HypoacusisEar and labyrinth disorders1/3441/890/900/88
Failure to ThriveMetabolism and nutrition disorders2/3441/890/900/88
PyrexiaGeneral disorders1/3440/891/900/88
AgitationPsychiatric disorders1/3440/891/900/88
Most frequent other events
Most frequent other events
EventOpen-Label Rabeprazole Sodium 10 mgDouble-Blind PlaceboDouble-Blind Rabeprazole Sodium 5 mgDouble-Blind Rabeprazole Sodium 10 mg
PyrexiaGeneral disorders22/3445/899/906/88
Upper Respiratory Tract InfectionInfections and infestations19/3446/893/908/88
DiarrhoeaGastrointestinal disorders21/3447/898/904/88
NasopharyngitisInfections and infestations19/3444/898/903/88
Blood Gastrin IncreasedInvestigations10/3440/892/907/88
Gastrooesophageal Reflux DiseaseGastrointestinal disorders13/3447/892/904/88
VomitingGastrointestinal disorders13/3445/896/902/88
ConstipationGastrointestinal disorders15/3444/892/905/88
Otitis MediaInfections and infestations14/3444/895/903/88
RashSkin and subcutaneous tissue disorders12/3444/895/902/88

Baseline characteristics

Age Continuous
Age Continuous(months)Open-Label Rabeprazole Sodium 10 mg
Mean4.6 ± 2.55
Sex: Female, Male
Sex: Female, Male(Participants)Open-Label Rabeprazole Sodium 10 mg
Female139
Male205
Region of Enrollment
Region of Enrollment(participants)Open-Label Rabeprazole Sodium 10 mg
AUSTRALIA7
BELGIUM11
BULGARIA24
HUNGARY51
ISRAEL36
ITALY5
NETHERLANDS9
POLAND56
SOUTH AFRICA12
UNITED STATES133
AgeCategorical
AgeCategorical(participants)Open-Label Rabeprazole Sodium 10 mg
>= 1 to < 4 Months175
>= 4 to < 8 Months124
>= 8 to < 12 Months45
08

Study locations

84 sites
  • Birmingham, Alabama, United States
  • Columbiana, Alabama, United States
  • Dothan, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Bentonville, Arkansas, United States
  • Orange, California, United States
  • Centennial, Colorado, United States
  • Thornton, Colorado, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Augusta, Georgia, United States
  • Park Ridge, Illinois, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Owensboro, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Flint, Michigan, United States
  • St. Paul, Minnesota, United States
  • Jackson, Mississippi, United States
  • Bridgeton, Missouri, United States
  • Mays Landing, New Jersey, United States
  • Valhalla, New Jersey, United States
  • Bronx, New York, United States
  • Buffalo, New York, United States
  • Utica, New York, United States
  • Charlotte, North Carolina, United States
  • Toledo, Ohio, United States
  • Youngstown, Ohio, United States
  • Gresham, Oregon, United States
  • Hershey, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Kingsport, Tennessee, United States
  • Dallas, Texas, United States
  • Laredo, Texas, United States
  • San Antonio, Texas, United States
  • Tomball, Texas, United States
  • Fairfax, Virginia, United States
  • Huntington, West Virginia, United States
  • Garran, Australia
  • Herston, Australia
  • Kogarah, Australia
  • Parkville, Australia
  • Sydney, Australia
  • Antwerpen, Belgium
  • Brussel, Belgium
  • Leuven, Belgium
  • Pleven, Bulgaria
  • Odense, Denmark
  • Budapest, Hungary
  • Békéscsaba, Hungary
  • Gyulai Ut 18, Hungary
  • Gyõr, Hungary
  • Miskolc, Hungary
  • Nyiregyhaza, Hungary
  • Pecs, Hungary
  • Szombathely, Hungary
  • Veszprem, Hungary
  • Veszprém, Hungary
  • Haifa, Israel
  • Jerusalem, Israel
  • Petach Tikvah, Israel
  • Petach Tikva, Israel
  • Ramat Gan, Israel
  • Tiberias, Israel
  • Amsterdam, Netherlands
  • Nijmegen, Netherlands
  • Zwolle, Netherlands
  • Bialystok, Poland
  • Bydgoszcz N/A, Poland
  • Bydgoszcz, Poland
  • Czestochowa, Poland
  • Rzeszow N/A, Poland
  • Rzeszow, Poland
  • Torun, Poland
  • Warszawa, Poland
  • Durbanville, South Africa
  • Durban, South Africa
  • Panorama, South Africa
  • Wynberg, South Africa
09

References and documents

Publications

  • Sharp WG, Stubbs KH, Adams H, Wells BM, Lesack RS, Criado KK, Simon EL, McCracken CE, West LL, Scahill LD. Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):658-63. doi: 10.1097/MPG.0000000000001043. PubMed 26628445 ↗
  • Hussain S, Kierkus J, Hu P, Hoffman D, Lekich R, Sloan S, Treem W. Safety and efficacy of delayed release rabeprazole in 1- to 11-month-old infants with symptomatic GERD. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):226-36. doi: 10.1097/MPG.0000000000000195. PubMed 24121146 ↗
  • Treem W, Hu P, Sloan S. Normal and proton pump inhibitor-mediated gastrin levels in infants 1 to 11 months old. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):520-6. doi: 10.1097/MPG.0b013e31829b6914. PubMed 23689261 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00992589
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Eisai Inc.
Responsible party
Sponsor
First posted
Oct 9, 2009
Start date
Nov 2009
Primary completion
Nov 2011
Completion
Nov 2011
Results posted
May 22, 2013
Last update
May 22, 2013

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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