CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
pantoprazole for approximately 9 weeks.drug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Endoscopically confirmed GERD diagnosed within 6 months before study entry
  • ✓Weight ≥8.3 kg; for children ≥6 years, weight ≤25 kg
Key exclusion· 2
  • ✕History of GI disorders including unrepaired tracheal esophageal fistula, GI malabsorption, or eosinophilic esophagitis
  • ✕Children aged 6–11 years unable to swallow tablets

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00141817
NCT00141817Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 1, 2005·Updated Dec 28, 2011

In Brief

A Phase 3 clinical trial evaluating pantoprazole for approximately 9 weeks. for Gastroesophageal Reflux. Completed, enrolled 41 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartAug 1, 2005
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

pantoprazole for approximately 9 weeks.drug