Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring | The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. | Baseline and end of treatment (10-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux | Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marta Illueca, MD | AstraZeneca | Study Director |
| Per Lundborg, MD | AstraZeneca | Study Director |
| Kathryn Collison, MPH, MT(ASCP) | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | North Adelaide | Australia | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23800403 | Derived | Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22. |
Not provided
Not provided
Not provided
Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. |
| FG001 | Placebo | Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| ||||||||||||||||||
| Study Completion to Safety Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole | Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring | The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. | Posted | Mean | Standard Deviation | Mean Number of Events | Baseline and end of treatment (10-14 days) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esomeprazole | Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia Neonatal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Neonatal | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Acidic Reflux Episodes | Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Weakly Acidic Reflux Episodes | Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Non Acidic Reflux Episodes | Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Mean Bolus Clearance Time | Based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Mean Acid Clearance Time | Based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Percentage Time With pH<4.0 | Percentage time with pH<4 during 24-hour pH monitoring | Baseline and end of treatment (10-14 days) |
| Change From Baseline in Percentage Time With pH Within 4.0-6.9 | Percentage time with pH 4.0-6.9 during 24-hour pH monitoring | Baseline and end of treatment (10-14 days) |
| Aachen |
| Germany |
| Research Site | Sheffield | United Kingdom |
| NOT COMPLETED |
|
|
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux | Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. | Posted | Mean | Standard Deviation | Mean Number of Events | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) | Number of reflux episodes based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Acidic Reflux Episodes | Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Weakly Acidic Reflux Episodes | Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Non Acidic Reflux Episodes | Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Mean Number of Episodes | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Mean Bolus Clearance Time | Based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Seconds | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Mean Acid Clearance Time | Based on 24-hour impedance monitoring data | Posted | Mean | Standard Deviation | Seconds | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Percentage Time With pH<4.0 | Percentage time with pH<4 during 24-hour pH monitoring | Posted | Mean | Standard Deviation | Percentage | Baseline and end of treatment (10-14 days) |
|
|
|
| Secondary | Change From Baseline in Percentage Time With pH Within 4.0-6.9 | Percentage time with pH 4.0-6.9 during 24-hour pH monitoring | Posted | Mean | Standard Deviation | Percentage | Baseline and end of treatment (10-14 days) |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Placebo | Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. | 3 | 7 | 7 | 7 |
| Cyanosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Inappropriate Device Signal Detection | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Infantile Apnoeic Attack | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Deafness Neurosensory | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retinopathy Of Prematurity | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neonatal Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary Tract Infection Neonatal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oxygen Saturation Decreased | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| D004066 | Digestive System Diseases |
| 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 |