Phase 3
Completed N=58
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Source: ClinicalTrials.gov NCT00868296 ↗Enrolled (actual)
58
Serious AEs
—
Results posted
Jan 2010
Primary outcomePrimary: Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period — 0; 3; 0; 1 patients
Summary
The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period |
0; 3; 0; 1; 0; 1 | — |
| PRIMARY Growth Parameters Z-scores |
0.33; -1.63; 0.45; -1.04; -0.16; -1.26 | 0.857 |
Eligibility Criteria
Inclusion Criteria
- Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.
Exclusion Criteria
- Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.
Data sourced from ClinicalTrials.gov (NCT00868296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.