Phase 3
Completed N=67
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Source: ClinicalTrials.gov NCT00259012 ↗Enrolled (actual)
67
Serious AEs
—
Results posted
May 2010
Primary outcomePrimary: Peak Concentration (Cmax) — 567; 1527 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Concentration (Cmax) |
567; 1527 | — |
| PRIMARY Time to Peak Concentration (Tmax) Profile |
1.03; 1.02 | — |
| PRIMARY Disposition Half-life |
1.78; 1.42 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC) |
1046; 3602 | — |
| PRIMARY Apparent Oral Clearance (CL/F) |
1.54; 0.87 | — |
| PRIMARY Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration |
289; 668; 69; 353 | — |
| PRIMARY Intragastric pH |
4.2; 3.0; 4.8; 4.2 | 0.087 |
| PRIMARY Median Intragastric pH |
4.2; 2.8; 4.7; 4.2 | 0.255 |
| PRIMARY Percentage of Time Intragastric pH Was >4 |
55.5; 32.2; 68.5; 56.6 | 0.099 |
| PRIMARY Mean Intraesophageal pH |
5.7; 5.2; 5.6; 4.9 | 0.347 |
| PRIMARY Median Intraesophageal pH |
5.8; 5.3; 5.6; 4.9 | 0.339 |
| PRIMARY Percentage of Time That Intraesophageal pH Was <4 |
4.6; 8.0; 4.6; 9.4 | 0.982 |
| PRIMARY Normalized Area of Gastric Hydrogen Ion Activity Over Time |
259.7; 921.0; 102.3; 303.6 | 0.166 |
| PRIMARY Normalized Area of Esophageal Hydrogen Ion Activity Over Time |
2.1; 3.5; 1.5; 1.5 | 0.387 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
Data sourced from ClinicalTrials.gov (NCT00259012). 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.