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| Sponsors and Collaborators: |
Wyeth Nycomed |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00259012 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux |
Drug: pantoprazole sodium enteric-coated spheroid suspension |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | 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 |
| Estimated Enrollment: | 92 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Arm 1- Low Dose pantoprazole
|
Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335
|
|
2: Active Comparator
Arm 2- active drug - pantoprazole
|
Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335
|
Eligibility| Ages Eligible for Study: | 1 Month to 11 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 31 Study Locations| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3001B3-333, 3001B3-335 |
| Study First Received: | November 23, 2005 |
| Last Updated: | July 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00259012 |
| Health Authority: | United States: Food and Drug Administration |
|
GERD Infant |
|
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Pantoprazole Esophageal Diseases Gastroesophageal Reflux |
|
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |
