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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005030-15 | EudraCT Number | ||
| 2023-508770-28-00 | Registry Identifier | CTIS (EU) |
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Pfizer has made an internal business decision to terminate the B1791094 study. This decision was not due to safety concerns or requests from any regulatory authorities.
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The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Full Dose Pantoprazole and matching placebo | Active Comparator | Full Healing Dose of pantoprazole |
|
| Arm 2 Half Dose Pantoprazole and matching placebo | Active Comparator | Half Healing Dose of pantoprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full dose Pantoprazole plus matching placebo | Drug | Full healing dose of pantoprazole plus matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures | Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in Physical Examinations and Vital Signs | Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate. | Baseline up to 36 weeks |
| Incidence of Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
Prior or Concomitant Therapy:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist/Wolfson's Children's Hospital | Jacksonville | Florida | 32207 | United States | ||
| Nemours Children's Health, Jacksonville |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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randomized, double-blind
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| Half Dose Pantoprazole plus matching placebo | Drug | Half healing dose of pantoprazole plus matching placebo |
|
| Baseline up to 36 weeks |
| Number of Participants With Change From Baseline in Laboratory Tests Results | Safety and tolerability will be assessed by clinical laboratory measurements | Baseline up to 36 weeks |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| University of Rochester | Rochester | New York | 14627 | United States |
| University of Rochester Medical Center Clinical Research Center | Rochester | New York | 14642 | United States |
| Board of Regents of the University of Wisconsin System | Madison | Wisconsin | 53715 | United States |
| UW Health E Terrace Dr Medical Center | Madison | Wisconsin | 53718 | United States |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53792 | United States |
| UW Health 2275 Deming Way Clinic | Middleton | Wisconsin | 53562 | United States |
| University clinical center of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| JSC Georgian Clinics | Tbilisi | 0159 | Georgia |
| LTD Imedi Clinic | Tbilisi | 0159 | Georgia |
| Georgian-American Family Medicine Clinic | Tbilisi | 0171 | Georgia |
| SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| Medical college and Hospital | Kolkata | West Bengal | 700073 | India |
| Hospital HIMA San Pablo Caguas | Caguas | 00725 | Puerto Rico |
| Chiara Biaggi de Casenave, MD | Guaynabo | 00969 | Puerto Rico |
| University Children's Hospital | Belgrade | 11000 | Serbia |
| University Clinical Center of Kragujevac | Kragujevac | 34000 | Serbia |
| Univerzitna nemocnica Martin, Klinika deti a dorastu | Martin | 036 59 | Slovakia |
| KM Management, spol. s r.o., | Nitra | 94901 | Slovakia |
| MDX Klinik Arastirma Egitim ve Danismanlik Ltd | Istanbul | 34880 | Turkey (Türkiye) |
| Izmir Saglik Bilimleri University Tepecik Training And Research Hospital | Izmir | 35340 | Turkey (Türkiye) |
| T.C. Saglik Bakanligi - Izmir Sehir Hastanesi | Izmir | 35540 | Turkey (Türkiye) |
| Evelina London Children's Hospital | London | SE1 7EH | United Kingdom |
| Guys & St Thomas Nhs Foundation | London | SE1 9RT | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Great Ormond Street Hospital For Children NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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