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The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Active Comparator |
| |
| High dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pantoprazole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive. | 6 weeks |
| Growth Parameters Z-scores | Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 6 weeks |
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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 |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, medinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For South Africa, ZAFinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
Patients were eligible for enrollment into the study after completion of either study 3001B3-331 (NCT00362609) or study 3001B3-333 (NCT00259012).
Patients were recruited worldwide March 2006 to February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Pantoprazole | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| For Switzerland, med@wyeth.com |
| Principal Investigator |
| Loma Linda |
| California |
| 92354 |
| United States |
| Oakland | California | 94609-1809 | United States |
| Orange | California | 92868 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103 | United States |
| New Haven | Connecticut | 06520-8064 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Gainesville | Florida | 32610-0296 | United States |
| Miami | Florida | 33101 | United States |
| Sunrise | Florida | 33323 | United States |
| Atlanta | Georgia | 30322 | United States |
| Honolulu | Hawaii | 96826 | United States |
| Boise | Idaho | 83704 | United States |
| Chicago | Illinois | 60614 | United States |
| Park Ridge | Illinois | 60068 | United States |
| Lexington | Kentucky | 40536-0284 | United States |
| Louisville | Kentucky | 40202 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Baltimore | Maryland | 21201 | United States |
| Boston | Massachusetts | 02114 | United States |
| Flint | Michigan | 48503 | United States |
| Omaha | Nebraska | 68105 | United States |
| Camden | New Jersey | 08103 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Newark | New Jersey | 07103 | United States |
| Albany | New York | 12208 | United States |
| Brooklyn | New York | 11219 | United States |
| New York | New York | 10032 | United States |
| The Bronx | New York | 10467 | United States |
| Valhalla | New York | 10595-1689 | United States |
| Durham | North Carolina | 27710 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Portland | Oregon | 97239-3042 | United States |
| Danville | Pennsylvania | 17822-1320 | United States |
| Memphis | Tennessee | 38163 | United States |
| Nashville | Tennessee | 37232-9550 | United States |
| Dallas | Texas | 75390-9063 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84113 | United States |
| Burlington | Vermont | 05401 | United States |
| Richmond | Virginia | 23298 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Brisbane | Australia |
| Edegem | 2650 | Belgium |
| Leuven | 3000 | Belgium |
| Vancouver | British Columbia | V6H 3V4 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto | Ontario | M5G 1X8 | Canada |
| Montreal | Quebec | H3H 1P3 | Canada |
| Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Paris | 75674 | France |
| Paris | 75935 | France |
| Bochum | 44797 | Germany |
| Osnabrück | 49074 | Germany |
| Potsdam | 14467 | Germany |
| Brescia | 25123 | Italy |
| Naples | 80121 | Italy |
| Roma | 00161 | Italy |
| Rotterdam | 3015 GJ | Netherlands |
| Bydgoszcz | 85-165 | Poland |
| Krakow | 33-663 | Poland |
| Lublin | 20-093 | Poland |
| Panorama | CPT | 7500 | South Africa |
| Pietermaritzburg | KwaZulu-Natal | 3235 | South Africa |
| Durban | 3630 | South Africa |
| Overport | 4067 | South Africa |
| Pretoria | 0083 | South Africa |
| Zurich | 8032 | Switzerland |
| FG001 | High Dose Pantoprazole | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Pantoprazole | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group. |
| BG001 | High Dose Pantoprazole | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| 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 | Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive. | Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38). | Posted | Nov 2009 | Number | patients | 6 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Growth Parameters Z-scores | Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | 6 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 | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group. | 1 | 8 | ||||
| EG001 | High Dose Pantoprazole | Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes. | 2 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental injury | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Hernia | General disorders | Non-systematic Assessment |
| ||
| Immune system disorder | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Injection site pain | General disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gingivitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oral moniliasis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tooth disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ecchymosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Creatine phosphokinase increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Healing abnormal | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Musculoskeletal anomaly | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Agitation | Nervous system disorders | Non-systematic Assessment |
| ||
| Hostility | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Non-systematic Assessment |
| ||
| Apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough increased | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary physical finding | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Herpes simplex | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Maculopapular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pustular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Blepharitis | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Eye disorder | Eye disorders | Non-systematic Assessment |
| ||
| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Vaginal moniliasis | Reproductive system and breast disorders | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| 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
| Male |
|
| Total bilirubin (µmol/L) |
|
| CPK (mU/mL) |
|
| Gastrin (pg/mL) |
|
| Neutrophils (1,000,000,000/L) |
|
| Platelet count (1,000,000,000/L) |
|
| Urine protein albumin |
|
| Urine leukocyte esterase |
|
Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes. |
|
|
|