You are here

Our science / Clinical Trials / Find a Trial / NCT00362609

Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Back to Search Print Save as PDF Bookmark Trial

NCT00362609

Last updated on August 9, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85006 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastroesophageal Reflux
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-28
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hospitalized patients

- Presumed diagnosis of GERD

- Term or post-term infants within the neonatal period less than 28 days or preterm
infants with a corrected gestational age of less than 44 weeks

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- cardiovascular instability

- clinically significant laboratory abnormalities

- use of warfarin, carbamazepine, phenytoin, or rifampin

NCT00362609
Pfizer
Completed
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Gastroesophageal Reflux Disease
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
NCT02401035
All Genders
1+
Years
Multiple Sites
Gastroesophageal Reflux
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT00365300
All Genders
0+
Years
Multiple Sites
Gastroesophageal Reflux
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
NCT00259012
All Genders
0+
Years
Multiple Sites
Gastroesophageal Reflux, Esophagitis
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
NCT00195208
All Genders
18+
Years
Multiple Sites
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: pantoprazole
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized patients
  • Presumed diagnosis of GERD
  • Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria:

  • cardiovascular instability
  • clinically significant laboratory abnormalities
  • use of warfarin, carbamazepine, phenytoin, or rifampin
Sexes Eligible for Study: All
up to 28 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Poland,   South Africa,   Switzerland,   United States
 
 
NCT00362609
3001B3-331, 3001B3-335
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Switzerland, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now