Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RABGRD3004 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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second week of the open-label treatment period will enter the double-blind treatment period; those who do not will be withdrawn from the study.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazole sodium 5 mg | Experimental |
| |
| Rabeprazole sodium 10 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole sodium 5 mg | Drug | Rabeprazole Sodium 5 mg capsules once daily in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) | Baseline, Week 8 | |
| 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). | Baseline, Week 8 |
| 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. | Baseline, Week 8 |
| 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. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period | Baseline, Week 8 | |
| Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26628445 | Derived | 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. | |
| 24121146 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Rabeprazole Sodium 10 mg | Rabeprazole Sodium capsules once daily in the morning. |
| FG001 | Double-Blind Placebo | Matching placebo capsules once daily in the morning. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rabeprazole sodium 10 mg | Drug | Rabeprazole Sodium 10 mg capsules once daily in the morning. |
|
| Placebo | Drug | Matching placebo capsules once daily in the morning. |
|
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.
| Baseline, Week 8 |
| 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. | Baseline, Week 8 |
| 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. | Baseline, Week 8 |
| 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 |
| Saint Paul | Minnesota | United States |
| Jackson | Mississippi | United States |
| Bridgeton | Missouri | United States |
| Mays Landing | New Jersey | United States |
| Valhalla | New Jersey | United States |
| Buffalo | New York | United States |
| The Bronx | 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 |
| Antwerp | Belgium |
| Brussels | Belgium |
| Leuven | Belgium |
| Pleven | Bulgaria |
| Odense | Denmark |
| Békéscsaba | Hungary |
| Budapest | Hungary |
| Gyõr | Hungary |
| Gyulai Ut 18 | Hungary |
| Miskolc | Hungary |
| Nyíregyháza | Hungary |
| Pécs | Hungary |
| Szombathely | Hungary |
| Veszprém | Hungary |
| Haifa | Israel |
| Jerusalem | Israel |
| Petach Tikvah | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Tiberias | Israel |
| Amsterdam | Netherlands |
| Nijmegen | Netherlands |
| Zwolle | Netherlands |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Częstochowa | Poland |
| Rzeszów | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Durban | South Africa |
| Durbanville | South Africa |
| Panorama | South Africa |
| Wynberg | South Africa |
| 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. |
| 23689261 | Derived | 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. |
| FG002 | Double-Blind Rabeprazole Sodium 5 mg | Rabeprazole Sodium capsules once daily in the morning. |
| FG003 | Double-Blind Rabeprazole Sodium 10 mg | Rabeprazole Sodium capsules once daily in the morning. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label Rabeprazole Sodium 10 mg | Rabeprazole Sodium capsules once daily in the morning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| AgeCategorical | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | frequency of Regurgitation | Baseline, Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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). | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | Z-score | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | number of episodes | Baseline, Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label Rabeprazole Sodium 10 mg | Rabeprazole Sodium capsules once daily in the morning. | 15 | 344 | 116 | 344 | ||
| EG001 | Double-Blind Placebo | Matching placebo capsules once daily in the morning. | 2 | 89 | 33 | 89 | ||
| EG002 | Double-Blind Rabeprazole Sodium 5 mg | Rabeprazole Sodium capsules once daily in the morning. | 8 | 90 | 34 | 90 | ||
| EG003 | Double-Blind Rabeprazole Sodium 10 mg | Rabeprazole Sodium capsules once daily in the morning. | 3 | 88 | 32 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | 12.0 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | 12.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Beta 2 Microglobulin Increased | Investigations | 12.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 12.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | 12.0 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | 12.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | 12.0 | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 12.0 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | 12.0 | Non-systematic Assessment |
| |
| Blood Gastrin Increased | Investigations | 12.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 12.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PORTFOLIO/CDT LEADER | Janssen R&D US | 1 609 730-2548 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| BULGARIA |
|
| HUNGARY |
|
| ISRAEL |
|
| ITALY |
|
| NETHERLANDS |
|
| POLAND |
|
| SOUTH AFRICA |
|
| UNITED STATES |
|
| >= 8 to < 12 Months |
|
| Double-Blind Rabeprazole Sodium Total |
Rabeprazole Sodium capsules once daily in the morning. |
|
|
|
| Double-Blind Rabeprazole Sodium 5 mg - Week 8 |
Rabeprazole Sodium capsules once daily in the morning. |
| OG005 | Double-Blind Rabeprazole Sodium 10 mg - Week 8 | Rabeprazole Sodium capsules once daily in the morning. |
| OG006 | Double-Blind Rabeprazole Sodium Total - Baseline | Rabeprazole Sodium capsules once daily in the morning. |
| OG007 | Double-Blind Rabeprazole Sodium Total - Week 8 | Rabeprazole Sodium capsules once daily in the morning. |
|
|
Rabeprazole Sodium capsules once daily in the morning. |
| OG003 | Double-Blind Rabeprazole Sodium Total | Rabeprazole Sodium capsules once daily in the morning. |
|
|
|
Rabeprazole Sodium capsules once daily in the morning. |
| OG003 | Double-Blind Rabeprazole Sodium Total | Rabeprazole Sodium capsules once daily in the morning. |
|
|
|
Rabeprazole Sodium capsules once daily in the morning. |
| OG003 | Double-Blind Rabeprazole Sodium Total | Rabeprazole Sodium capsules once daily in the morning. |
|
|
|
Rabeprazole Sodium capsules once daily in the morning.
| OG003 | Double-Blind Rabeprazole Sodium Total | Rabeprazole Sodium capsules once daily in the morning. |
|
|
|
Rabeprazole Sodium capsules once daily in the morning. |
| OG003 | Double-Blind Rabeprazole Sodium Total | Rabeprazole Sodium capsules once daily in the morning. |
|
|
|