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| Name | Class |
|---|---|
| Nycomed | INDUSTRY |
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To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Arm 1- Low Dose pantoprazole |
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| 2 | Active Comparator | Arm 2- Medium Dose pantoprazole |
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| 3 | Active Comparator | Arm 3- High Dose pantoprazole |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pantoprazole sodium enteric-coated spheroid | Drug | pediatric spheroids taken daily x 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36604 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20522615 | Derived | Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3. |
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Patients were screened for up to four weeks.
Patients were recruited in the United States and Canada from May 2006 to February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks |
| FG001 | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and 8 weeks |
| Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. | Baseline and 8 weeks |
| Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study | Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration). | 8 weeks |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Oakland | California | 94609 | United States |
| Orange | California | 92868 | United States |
| Sacramento | California | 95819 | United States |
| San Diego | California | 92103 | United States |
| Wilmington | Delaware | 19803 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32207 | United States |
| Miami | Florida | 33101 | United States |
| Orlando | Florida | 32806 | United States |
| Pensacola | Florida | 32504 | United States |
| Peoria | Illinois | 61603 | United States |
| Lexington | Kentucky | 40536 | United States |
| Louisville | Kentucky | 40202 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115 | United States |
| Flint | Michigan | 48503 | United States |
| Southfield | Michigan | 48075 | United States |
| Jackson | Mississippi | 39216 | United States |
| Omaha | Nebraska | 68105 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Egg Harbor | New Jersey | 08234 | United States |
| Morristown | New Jersey | 07962 | United States |
| Buffalo | New York | 14222 | United States |
| New York | New York | 10032 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Danville | Pennsylvania | 17822-1320 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | 76508 | United States |
| Norfolk | Virginia | 23507 | United States |
| Charleston | West Virginia | 25304 | United States |
| Huntington | West Virginia | 25701-3655 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Edmonton | Alberta | T6G 2B7 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| London | Ontario | N6A 4G5 | Canada |
| Ottawa | Ontario | K1H 8L1 | Canada |
| Montreal | Quebec | H3H 1P3 | Canada |
| Montreal | Quebec | H3T 1C5 | Canada |
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
| FG002 | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks |
| BG001 | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks |
| BG002 | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period. | The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period). | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | Baseline and 8 weeks |
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| Secondary | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. | The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | Baseline and 8 weeks |
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| Secondary | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. | The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question <3 times in a week. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | Baseline and 8 weeks |
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| Secondary | Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study | Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration). | The analysis population is randomized patients with erosive esophagitis at baseline. | Posted | Nov 2009 | Number | patients | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks | 0 | 18 | ||||
| EG001 | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks | 1 | 19 | ||||
| EG002 | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years. | 1 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
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| Accidental injury | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Flu syndrome | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Infection | General disorders | Non-systematic Assessment |
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| Injection site hypersensitivity | General disorders | Non-systematic Assessment |
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| Lab test abnormal | General disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Hemorrhage | Cardiac disorders | Non-systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Tooth cavities | Gastrointestinal disorders | Non-systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Ecchymosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperlipemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Peripheral edema | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Ataxia | Nervous system disorders | Non-systematic Assessment |
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| Hyperkinesia | Nervous system disorders | Non-systematic Assessment |
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| Sleep disorder | Nervous system disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough increased | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Laryngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Contact dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Exfoliative dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Maculopapular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
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| Eye pain | Eye disorders | Non-systematic Assessment |
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| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Vulvovaginal disorder | Reproductive system and breast disorders | Non-systematic Assessment |
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The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| Week 3 Change from Baseline |
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| Week 4 Change from Baseline |
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| Week 5 Change from Baseline |
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| Week 6 Change from Baseline |
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| Week 7 Change from Baseline |
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| Week 8 Change from Baseline |
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| Final Week Change from Baseline |
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| 0.063 |
| No |
| Superiority or Other |
| Within group analysis of final week change from baseline. | t-test, 2 sided | < 0.001 | No | Superiority or Other |
| Between group analysis of final week change from baseline. | ANCOVA | Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates | 0.004 | No | Superiority or Other |
| Between group analysis of final week change from baseline. | ANCOVA | Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates | 0.082 | No | Superiority or Other |
| Between group analysis of final week change from baseline. | ANCOVA | Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates | 0.217 | No | Superiority or Other |
Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
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