Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821310
• Other study ID #: B1791094
• Secondary ID: 2020-005030-15
• Status: Recruiting
• Phase: Phase 2
• Start date: January 13, 2022
• Est. completion date: December 9, 2027

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 9, 2027
• Est. primary completion date: December 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis

Intervention

Drug:
• Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
• Half Dose Pantoprazole plus matching placebo
Half healing dose of pantoprazole plus matching placebo

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Bosnia and Herzegovina	University clinical center of the Republic of Srpska	Banja Luka
Georgia	Evex clinic after I. Tsitsishvili	Tbilisi
Georgia	Georgian-American Family Medicine Clinic	Tbilisi
Georgia	LTD Imedi Clinic	Tbilisi
Georgia	New Hospitals	Tbilisi
Georgia	Pediatric Clinic after G. Zhvania	Tbilisi
Hungary	Heim Pal Pediatric Hospital	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szegedi Tudományegyetem	Szeged	Csongrád
India	Sanjeevani Children's Hospital	Aurangabad	Maharashtra
India	SR Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Yashoda Hospitals	Secunderabad	Telangana
India	Gujarat Hospital - Gastro & Vascular Centre	Surat	Gujarat
Puerto Rico	Hospital HIMA San Pablo Caguas	Caguas
Puerto Rico	Chiara Biaggi de Casenave, MD	Guaynabo
Puerto Rico	Puerto Rico Consortium for Clinical Investigation	San Juan
Serbia	University Children's Hospital	Belgrade
Serbia	University Clinical Center of Kragujevac	Kragujevac
Slovakia	Detska fakultna nemocnica s poliklinikou Banska Bystrica	Banska Bystrica
Slovakia	Narodny ustav detskych chorob	Bratislava
Slovakia	Univerzitna nemocnica Martin, Klinika deti a dorastu	Martin
Slovakia	KM Management, spol. s r.o.,	Nitra
Turkey	SBU Izmir Tepecik EAH	Izmir
Turkey	T.C. Saglik Bakanligi - Izmir Sehir Hastanesi	Izmir
United Kingdom	Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust	Carshalton
United Kingdom	Evelina London Children's Hospital	London
United Kingdom	Great Ormond Street Hospital For Children NHS Foundation Trust	London
United Kingdom	Great Ormond Street Hospital For Children NHS Foundation Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Royal Free Hospital	London
United States	Children's Healthcare of Atlanta - Center for Advanced Pediatrics	Atlanta	Georgia
United States	Children's Healthcare of Atlanta-Egleston	Atlanta	Georgia
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Children's Health / Children's Medical Center	Dallas	Texas
United States	Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)	Huntington	West Virginia
United States	University Physicians and Surgeons, Inc dba Marshall Health	Huntington	West Virginia
United States	Baptist/Wolfson's Children's Hospital	Jacksonville	Florida
United States	Nemours Children's Specialty Care	Jacksonville	Florida
United States	University Hospital and UW Health Clinics	Madison	Wisconsin
United States	UW Health E Terrace Dr Medical Center	Madison	Wisconsin
United States	UW Health 2275 Deming Way Clinic	Middleton	Wisconsin
United States	Childrens Hospital of Orange County	Orange	California
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Unity Point Health Pediatric Gastroenterology	Peoria	Illinois
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center Clinical Research Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Bosnia and Herzegovina,  Georgia,  Hungary,  India,  Puerto Rico,  Serbia,  Slovakia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Incidence of Adverse Events (AEs)		Baseline up to 36 weeks
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.