Phase 3 Completed N=59 Randomized Treatment

Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Gastroesophageal Reflux Disease

Source: ClinicalTrials.gov NCT00362609 ↗

Enrolled (actual)

Serious AEs

—

Results posted

May 2010

Primary outcomePrimary: Variance of Oral Bioavailability — 1.07; 0.74 ratio

Summary

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY Variance of Oral Bioavailability	1.07; 0.74	—
SECONDARY Area Under the Concentration-time Curve (AUC)	3540; 7270	—
SECONDARY Apparent Oral Clearance (Cl/F)	0.21; 0.23	—
SECONDARY Half Life	3.1; 2.7	—

Eligibility Criteria

Inclusion Criteria

Hospitalized patients
Presumed diagnosis of GERD
Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria

cardiovascular instability
clinically significant laboratory abnormalities
use of warfarin, carbamazepine, phenytoin, or rifampin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00362609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.