None listed
Conditions
Interventions
group from 3 months to 12 years Type of group
patients from five days to three months of age will be assigned either to the Axid ® group (nizatldine) 2.5 mg/kg/12hs. (as suspension) or to the Axid ® group (nizatldine) 5 mg/kg/12hs.
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion criteria
Inclusion criteria: • The subjects must, in the opinion of the responsible physician, have the possibility of benefiting from gastric acid suppression. • Subjects between 5 days and 12 years of age. • They must weigh at least 2.6 kg at the time of recruitment and be between the 5th and 10th percentiles, adapted to the height and weight of the participant. • Must have a Parent / Guardian Consent Form Informed for the Study • Axid 9008 approved by the Institutional Review Commission (CRI) and by the Independent Ethics Committee (CIE) and signed by the parent or legal guardian.
Exclusion criteria
Exclusion criteria: • Rings or esophageal strictures, or esophagitis secondary to systemic events. • Primary disorders of esophageal motility. • History of esophageal and / or gastric varices. • Current treatment with ulcerogenic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The percentage of time that intraesophageal and intragastric pH will be> 4.0 during the 12-hour probe will be determined. To achieve this goal, a linear model based on age, the baseline of the median pH and the dose level will be used. The baseline of the median pH will be obtained from the pH measurement of the basic 30-minute period. Measure:Relationship between the plasmatic concentration of nlzatidine and its effect on the intranasal pH after an initial oral dose of nizatidine. Timepoints:day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Tests will be carried out to determine the median and mean intraesophageal and intragastric pH during pH measurements with a 12-hour probe. Changes in intraesophageal and intragastric pH with respect to the baseline will be calculated as the median pH over the pH measurement of 12 hours minus the median on the 30-minute baseline pH measurement. In addition it will be evaluated: 1) total number of reflux episodes 2) number of reflux episodes that last more than 5 minutes 3) average duration of reflux episodes A) duration of the most prolonged reflux episode 5) Total time with a pH <4.0. Measure:To analyze the relationship between plasma concentration of nizatidine and its effect on intragastric and intraesophageal pH. Timepoints:After day 9 | — |
Countries
Peru, United States
Outcome results
None listed