Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Gastroesophageal Reflux, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
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 2,884-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00259012 record still lists
NCT00259012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 2,884-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (98% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00259012's enrollment target sits among peer trials
67 19th of 33 higher than 15 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
COMPLETED · Phase 3
-
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
COMPLETED · Phase 3
-
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
COMPLETED · Phase 3
-
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
RECRUITING · NA
-
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
RECRUITING · NA
-
Compassionate Use of Domperidone for Refractory Gastroparesis
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03213002 · 67 participants · Phase 1
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
- NCT04115163 · 67 participants · Phase 2
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
- NCT04315324 · 67 participants · Phase 1
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
- NCT04532424 · 67 participants · NA
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia