Clinical trial NCT04821310: Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
Official title: AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Esophagitis
Keywords: Erosive
esophagitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment:
* Capable of giving signed informed consent/assent
* Willingness and ability of the participant or parent/legal guardian to complete the eDiary
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
* Male and female participants aged 1 to 17 years.
* Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participant's age.
* To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria :
* Premenarchal: The investigator (or other appropriate staff) must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered "female participants of non childbearing potential" and must comply with the protocol requirements applicable to women of childbearing potential.

Exclusion Criteria:

* Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation
* History or presence of upper gastrointestinal anatomic or motor disorders
* Family history of malignant hyperthermia
* Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the excipients.
* Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid, carbamazepine, and griseofulvin).
* Serum creatine kinase levels \>3 x upper limit of normal.
* Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome.
* Active malignancy of any type, or history of a malignancy. Participants 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.
* Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit.
* Alanine aminotransferase or blood urea nitrogen \>2.0 upper limit of normal or estimated creatinine \>1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1).
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Has, in the Investigator's opinion, a serious chronic condition (eg, diabetes, epilepsy), which is either not stable or not well controlled and may interfere with the conduct of the study.
* Has any condition possibly affecting drug absorption (eg, gastrectomy).

Prior or Concomitant Therapy:

* Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
* Pregnant female participants; breastfeeding female participants.
* Is unwilling or unable to comply with the Lifestyle Considerations section

Primary outcomes:
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With Change From Baseline in Physical Examinations and Vital Signs
timeFrame: Baseline up to 36 weeks
measure: Incidence of Adverse Events (AEs)
timeFrame: Baseline up to 36 weeks
measure: Number of Participants With Change From Baseline in Laboratory Tests Results
timeFrame: Baseline up to 36 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: Jacksonville
country: United States
facility: Baptist/Wolfson's Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta-Egleston
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Peoria
country: United States
facility: Unity Point Health Pediatric Gastroenterology
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester Medical Center Clinical Research Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Health / Children's Medical Center
state: Texas
city: Huntington
country: United States
facility: Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)
state: West Virginia
city: Huntington
country: United States
facility: University Physicians and Surgeons, Inc dba Marshall Health
state: West Virginia
city: Madison
country: United States
facility: UW Health E Terrace Dr Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Middleton
country: United States
facility: UW Health 2275 Deming Way Clinic
state: Wisconsin
city: Brussel
country: Belgium
facility: UZ Brussel
city: Banja Luka
country: Bosnia and Herzegovina
facility: University clinical center of the Republic of Srpska
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: JSC Georgian Clinics
city: Tbilisi
country: Georgia
facility: LTD Imedi Clinic
city: Tbilisi
country: Georgia
facility: Pediatric Clinic after G. Zhvania
city: Tbilisi
country: Georgia
facility: Georgian-American Family Medicine Clinic
city: Tbilisi
country: Georgia
facility: Evex clinic after I. Tsitsishvili
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
state: Csongrád
city: Budapest
country: Hungary
facility: Heim Pal Pediatric Hospital
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Surat
country: India
facility: Gujarat Hospital - Gastro & Vascular Centre
state: Gujarat
city: Aurangabad
country: India
facility: Sanjeevani Children's Hospital
state: Maharashtra
city: Jaipur
country: India
facility: SR Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Secunderabad
country: India
facility: Yashoda Hospitals
state: Telangana
city: Kolkata
country: India
facility: Medical college and Hospital
state: WEST Bengal
city: Caguas
country: Puerto Rico
facility: Hospital HIMA San Pablo Caguas
city: Guaynabo
country: Puerto Rico
facility: Chiara Biaggi de Casenave, MD
city: San Juan
country: Puerto Rico
facility: Puerto Rico Consortium for Clinical Investigation
city: Belgrade
country: Serbia
facility: University Children's Hospital
city: Kragujevac
country: Serbia
facility: University Clinical Center of Kragujevac
city: Banska Bystrica
country: Slovakia
facility: Detska fakultna nemocnica s poliklinikou Banska Bystrica
city: Bratislava
country: Slovakia
facility: CLINIQ s.r.o.
city: Bratislava
country: Slovakia
facility: Narodny ustav detskych chorob
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin, Klinika deti a dorastu
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.,
city: Izmir
country: Turkey
facility: SBU Izmir Tepecik EAH
city: Izmir
country: Turkey
facility: T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
city: Carshalton
country: United Kingdom
facility: Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Evelina London Children's Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: