Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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 (e.g., 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 (e.g., gastrectomy).
Prior or Concomitant Therapy:
- Frequent, repeated use of oral or parenteral glucocorticoids (e.g., 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.