Phase 3 Completed N=41 Randomized Treatment

Study Evaluating Pantoprazole in Children With GERD

Source: ClinicalTrials.gov NCT00141817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 136; 798; 1643; 2067 nanogram per milliliter (ng/mL)

Summary

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Plasma Concentration (Cmax)	136; 798; 1643; 2067	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax)	1.45; 2.71; 2.08; 2.03	—
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	208.96; 2273.96; 2448.61; 3190.96	—
PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	293.29; 2448.08; 2497.13; 3782.49	—
PRIMARY Plasma Decay Half-Life (t1/2)	5.34; 1.68; 0.77; 0.70	—
PRIMARY Apparent Oral Clearance (CL/F)	2.08; 1.28; 0.41; 0.40	—
PRIMARY Terminal-Phase Volume of Distribution (Vz/F)	12.22; 2.89; 0.43; 0.40	—
PRIMARY Plasma Concentrations After Multiple Doses	212.30; 486.49; 592.32; 2337.89; 503.25; 207.23	—

Eligibility Criteria

Inclusion Criteria

Endoscopically proven GERD diagnosed within 6 months before study entry.
Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria

History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
Subjects 6-11 years old unable to swallow tablets

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00141817). 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.