CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
pantoprazole sodium enteric-coated spheroiddrug
Likely dose
Pantoprazole sodium enteric-coated spheroids (pediatric formulation) taken daily for 8 weeksAI-extracted
Key inclusion· 3
  • ✓Ages 1 through 5 years
  • ✓Endoscopically confirmed GERD with positive endoscopic evidence of reflux-related esophagitis or positive histologic evidence of esophagitis consistent with GERD
  • ✓Ability to undergo endoscopy with required biopsy
Key exclusion· 3
  • ✕History or presence of upper gastrointestinal anatomic or motor disorders
  • ✕Known current or active cow's milk allergy
  • ✕Malignancy

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

Search/NCT00300755
NCT00300755Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 9, 2006·Updated May 19, 2010

In Brief

A Phase 3 clinical trial evaluating pantoprazole sodium enteric-coated spheroid for Gastroesophageal Reflux. Completed, enrolled 60 participants across 43 sites in 2 countries.

Detailed Summary

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesCanada, United States
CollaboratorsNycomed

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.3 years ago

Interventions

pantoprazole sodium enteric-coated spheroiddrug

pediatric spheroids taken daily x 8 weeks