CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
pantoprazole sodium enteric-coated spheroid suspensiondrug
Likely dose
Pantoprazole sodium enteric-coated spheroid suspension taken daily for 7 daysAI-extracted
Key inclusion· 3
  • ✓Age greater than 44 weeks beyond neonatal period but less than 12 months
  • ✓Presumptive diagnosis of GERD
  • ✓Weight greater than 2.5 kg but less than 15 kg
Key exclusion· 2
  • ✕History of gastrointestinal disorders including unrepaired tracheal esophageal fistula and GI malabsorption
  • ✕Clinically significant medical or surgical abnormalities

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

Search/NCT00259012
NCT00259012Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Nov 28, 2005·Updated May 7, 2010

In Brief

A Phase 3 clinical trial evaluating pantoprazole sodium enteric-coated spheroid suspension for Gastroesophageal Reflux. Completed, enrolled 67 participants across 31 sites in 8 countries.

Detailed Summary

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesAustralia, Belgium, France, Germany, Italy, Poland, Switzerland, United States
CollaboratorsNycomed

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2005
Enrollment StartNov 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.6 years ago

Interventions

pantoprazole sodium enteric-coated spheroid suspensiondrug

pediatric suspension taken daily x 7 days