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NCT00259012 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

A Phase 3 study of Gastroesophageal Reflux, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 3
Development phase
67
Enrollment target
20
Study locations

NCT00259012 is a Phase 3 study of Gastroesophageal Reflux that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 67 participants, below the 182-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT00259012, a Phase 3 study of Gastroesophageal Reflux, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
67 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Gastroesophageal Reflux

Interventions

  • DRUG pantoprazole sodium enteric-coated spheroid suspension

Study Locations (20)

Other

  • - Brisbane
  • - Antwerp
  • - Brussels
  • - Ghent

California

  • - Loma Linda
  • - San Diego

Florida

  • - Miami
  • - Pensacola

Illinois

  • - Chicago
  • - Park Ridge

Arkansas

  • - Little Rock

District of Columbia

  • - Washington D.C.

Kentucky

  • - Louisville

Louisiana

  • - Shreveport

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2005-11
Est. Completion 2008-03
Phase Phase 3

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

167 total trials

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What the Registry Record Tells You About NCT00259012

The ClinicalTrials.gov registry entry for NCT00259012 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (63% lower). The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which pantoprazole sodium enteric-coated spheroid suspension is the first listed.

NCT00259012 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00259012 about?

NCT00259012 is a clinical study titled "Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD". 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.

What is the current status of trial NCT00259012?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2005-11. Estimated completion is 2008-03.

What conditions does trial NCT00259012 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux.

What interventions are being tested in trial NCT00259012?

The interventions under investigation include: pantoprazole sodium enteric-coated spheroid suspension (DRUG).

Who is sponsoring clinical trial NCT00259012?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00259012 being conducted?

This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.