Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-21 @ 9:53 PM
Study NCT ID:
NCT02401035
Status:
TERMINATED
Last Update Posted:
2024-04-09
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 up to 34 days after the last dose (maximum up to 41 days)', 'description': 'Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Catheter site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vessel puncture site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Epiphyses delayed fusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'seriousEvents': [{'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clearance (CL) of Pantoprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.930', 'spread': '82', 'groupId': 'OG000'}, {'value': '4.739', 'spread': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.', 'unitOfMeasure': 'Liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution (Vd) of Pantoprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.622', 'spread': '58', 'groupId': 'OG000'}, {'value': '5.584', 'spread': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '5259', 'spread': '60', 'groupId': 'OG000'}, {'value': '4280', 'spread': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1', 'description': 'The results for Cmax were presented separately for single dose and multiple doses.', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pantoprazole: Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '5259', 'spread': '60', 'groupId': 'OG000'}, {'value': '4423', 'spread': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '6022', 'spread': '84', 'groupId': 'OG000'}, {'value': '6533', 'spread': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)', 'description': 'The results for AUC24 were presented separately for single dose and multiple doses.', 'unitOfMeasure': 'Nanogram* hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '5705', 'spread': '82', 'groupId': 'OG000'}, {'value': '6690', 'spread': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Since dosing interval between 2 doses are 24 hours, individual post-hoc estimated AUC from population PK analysis is AUC24. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '6022', 'spread': '84', 'groupId': 'OG000'}, {'value': '6542', 'spread': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1', 'description': 'The results for AUCinf were presented separately for single dose and multiple doses.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '5708', 'spread': '82', 'groupId': 'OG000'}, {'value': '6707', 'spread': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Pantoprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.805', 'spread': '0.1909', 'groupId': 'OG000'}, {'value': '3.767', 'spread': '0.6802', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to CYP2C19 Genotyping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to 34 days after the last dose (maximum up to 41 days)', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At screening (Day 0)', 'description': 'Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'OG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged greater than or equal to (\\>=) 1 year to less than (\\<) 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 milligrams (mg), once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'FG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 19 participants were enrolled. Nineteen participants were randomized and assigned to a study treatment out of which, 1 participant was not randomized to any study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 (>=1 to < 2 Years)', 'description': 'Participants aged \\>= 1 year to \\< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'BG001', 'title': 'Cohort 2 (>=2 to <16 Years)', 'description': 'Participants aged \\>= 2 to \\< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '0.000', 'groupId': 'BG000'}, {'value': '9.31', 'spread': '4.729', 'groupId': 'BG001'}, {'value': '8.00', 'spread': '5.323', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants were included in analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-07', 'size': 444624, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-11T19:17', 'hasProtocol': True}, {'date': '2022-10-03', 'size': 2146748, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-11T15:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \\<2 years of age cohort.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2014-12-15', 'resultsFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance (CL) of Pantoprazole', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.'}, {'measure': 'Volume of Distribution (Vd) of Pantoprazole', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1', 'description': 'The results for Cmax were presented separately for single dose and multiple doses.'}, {'measure': 'Cmax of Pantoprazole: Multiple Dose', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)', 'description': 'The results for AUC24 were presented separately for single dose and multiple doses.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose', 'timeFrame': '0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1', 'description': 'The results for AUCinf were presented separately for single dose and multiple doses.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose', 'timeFrame': '0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7', 'description': 'Data reported below is combined for Days 2 and 7.'}, {'measure': 'Terminal Half-Life (t1/2) of Pantoprazole', 'timeFrame': '0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7', 'description': 'Data reported below is combined for Days 1, 2 and 7.'}, {'measure': 'Number of Participants According to CYP2C19 Genotyping', 'timeFrame': 'Day 1', 'description': 'CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From Day 1 up to 34 days after the last dose (maximum up to 41 days)', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage.'}, {'measure': 'Number of Participants With Laboratory Abnormalities of Potential Clinical Concern', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.'}, {'measure': 'Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern', 'timeFrame': 'At screening (Day 0)', 'description': 'Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.'}, {'measure': 'Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.'}, {'measure': 'Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern', 'timeFrame': 'Up to Day 9', 'description': 'Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['candidate for acid suppression therapy', 'presumptive diagnosis of GERD', 'clinical diagnosis of suspected GERD', 'symptomatic GERD', 'endoscopically proven GERD'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1791089', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.', 'detailedDescription': 'In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:\n\nPrimary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.\n\nTo characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.\n\nSecondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.\n\nTo assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.\n* Body weight \\> 5th percentile for age.\n* Y-site or dedicated IV line for administration of pantoprazole sodium.\n* Expected survival for at least 30 days.\n* Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.\n\nExclusion Criteria:\n\n* Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n* Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.\n* Serum CK levels \\>3x ULN.\n* Known history of HIV or clinical manifestations of AIDS.\n* Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.\n* History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.\n* Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.\n* Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.\n* Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.\n* Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).\n* ALT or BUN \\>2.0 ULN or estimated creatinine \\>1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.\n* In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.\n* History of sensitivity to heparin or heparin induced thrombocytopenia."}, 'identificationModule': {'nctId': 'NCT02401035', 'briefTitle': 'PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY', 'orgStudyIdInfo': {'id': 'B1791089'}, 'secondaryIdInfos': [{'id': '2014-002182-29', 'type': 'EUDRACT_NUMBER'}, {'id': 'B1791089', 'type': 'OTHER', 'domain': 'Study Number'}, {'id': 'GERD', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV pantoprazole', 'description': 'Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.', 'interventionNames': ['Drug: IV pantoprazole']}], 'interventions': [{'name': 'IV pantoprazole', 'type': 'DRUG', 'description': 'Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight', 'armGroupLabels': ['IV pantoprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75207', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Health Specialty Center Dallas Campus", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'C1426BOS', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Militar Central "Cirujano Mayor Dr. Cosme Argerich"'}, {'zip': '78000', 'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'University clinical center of the Republic of Srpska', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'JSC Evex Medical Corporation', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Imedi Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Katholisches Klinikum Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Zentralapotheke St. Josef-Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'Centro Trials - Dipartimento Pediatrico Universitario Ospedaliero Padiglione Salviati', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS-Ospedale Pediatrico Bambino Gesù Farmacia Ospedaliera', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': "University Children's Clinic", 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Institute for Child and Youth Health Care of Vojvodina', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'zip': '833 40', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Narodny ustav detskych chorob', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '036 59', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Univerzitna nemocnica Martin', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '49006', 'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Komunalne pidpryiemstvo Dnipropetrovskyi spetsializovanyi klinichnyi medychnyi tsentr materi', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Komunalne nekomertsiine pidpryiemstvo Ivano-Frankivska oblasna dytiacha klinichna likarnia', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '73013', 'city': 'M. Kherson', 'country': 'Ukraine', 'facility': 'Komunalne nekomertsiine pidpryiemstvo "Khersonska dytiacha oblasna klinichna likarnia"'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}