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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04821310
Collaborator
(none)
110
Enrollment
25
Locations
2
Arms
70.8
Anticipated Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Full dose Pantoprazole plus matching placebo
  • Drug: Half Dose Pantoprazole plus matching placebo
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, double-blindrandomized, double-blind
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 13, 2022
Anticipated Primary Completion Date :
Dec 9, 2027
Anticipated Study Completion Date :
Dec 9, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1 Full Dose Pantoprazole and matching placebo

Full Healing Dose of pantoprazole

Drug: Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
Active Comparator: Arm 2 Half Dose Pantoprazole and matching placebo

Half Healing Dose of pantoprazole

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

Outcome Measures

Primary Outcome Measures

  1. 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 [Week 24]

    Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.

Secondary Outcome Measures

  1. Number of Participants With Change From Baseline in Physical Examinations and Vital Signs [Baseline up to 36 weeks]

    Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate.

  2. Incidence of Adverse Events (AEs) [Baseline up to 36 weeks]

  3. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline up to 36 weeks]

    Safety and tolerability will be assessed by clinical laboratory measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childrens Hospital of Orange County Orange California United States 92868
2 Baptist/Wolfson's Children's Hospital Jacksonville Florida United States 32207
3 Nemours Children's Specialty Care Jacksonville Florida United States 32207
4 The University of Chicago Medical Center Chicago Illinois United States 60637
5 Unity Point Health Pediatric Gastroenterology Peoria Illinois United States 61602
6 Methodist Medical Center of Illinois Peoria Illinois United States 61603
7 Methodist Medical Center of Illinois Peoria Illinois United States 61636
8 University of Rochester Medical Center Rochester New York United States 14642
9 Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only) Huntington West Virginia United States 25701
10 University Physicians and Surgeons, Inc dba Marshall Health Huntington West Virginia United States 25701
11 UZ Brussel Brussel Belgium 1090
12 University clinical center of the Republic of Srpska Banja Luka Bosnia and Herzegovina 78000
13 New Hospitals Tbilisi Georgia 0114
14 LTD Imedi Clinic Tbilisi Georgia 0159
15 Pediatric Clinic after G. Zhvania Tbilisi Georgia 0159
16 Georgian-American Family Medicine Clinic Tbilisi Georgia 0171
17 Evex clinic after I. Tsitsishvili Tbilisi Georgia Georgia
18 Szegedi Tudományegyetem Szeged Csongrád Hungary 6726
19 Heim Pal Pediatric Hospital Budapest Hungary 1089
20 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
21 Hospital HIMA San Pablo Caguas Caguas Puerto Rico 00725
22 Chiara Biaggi de Casenave, MD Guaynabo Puerto Rico 00969
23 University Clinical Center of Kragujevac Kragujevac Serbia 34000
24 SBU Izmir Tepecik EAH Izmir Turkey 35180
25 Evelina London Children's Hospital London United Kingdom SE1 7EH

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04821310
Other Study ID Numbers:
  • B1791094
  • 2020-005030-15
First Posted:
Mar 29, 2021
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Erosive
esophagitis
Additional relevant MeSH terms:
Esophagitis
Pantoprazole

Study Results

No Results Posted as of Aug 23, 2022