Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

NCT00362609 | Completed Phase 3 Results

• 1 other identifier: 3001B3-331, 3001B3-335
• Study Type: interventional
• Target: 59
• Locations: 11 countries
• Sites: 71

Brief Summary

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

Conditions

Gastroesophageal Reflux

Keywords

Safety

Outcome Measures

Primary Outcomes (1)

• Variance of Oral Bioavailability

  Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was \>1.2.

  1 day

Secondary Outcomes (3)

• Area Under the Concentration-time Curve (AUC)

  Baseline to 24 hours post dose on Day 1

• Apparent Oral Clearance (Cl/F)

  1 day

• Half Life

  1 day

Study Arms (2)

Low dose

ACTIVE COMPARATOR

Drug: pantoprazole

High dose

ACTIVE COMPARATOR

Drug: pantoprazole

Interventions

pantoprazole DRUG

High dose; Low dose

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• cardiovascular instability
• clinically significant laboratory abnormalities
• use of warfarin, carbamazepine, phenytoin, or rifampin

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (71)

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Phoenix, Arizona, 85006, United States

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Loma Linda, California, 92354, United States

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Oakland, California, 94609-1809, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92103, United States

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New Haven, Connecticut, 06520-8064, United States

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Washington D.C., District of Columbia, 20010, United States

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Gainesville, Florida, 32610-0296, United States

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Miami, Florida, 33101, United States

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Sunrise, Florida, 33323, United States

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Atlanta, Georgia, 30322, United States

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Honolulu, Hawaii, 96826, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60614, United States

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Park Ridge, Illinois, 60068, United States

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Lexington, Kentucky, 40536-0284, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02114, United States

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Flint, Michigan, 48503, United States

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Omaha, Nebraska, 68105, United States

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Camden, New Jersey, 08103, United States

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New Brunswick, New Jersey, 08901, United States

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Newark, New Jersey, 07103, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11219, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10467, United States

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Valhalla, New York, 10595-1689, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97239-3042, United States

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Danville, Pennsylvania, 17822-1320, United States

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37232-9550, United States

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Dallas, Texas, 75390-9063, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84113, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23298, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53226, United States

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Brisbane, Australia

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Vancouver, British Columbia, V6H 3V4, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Toronto, Ontario, M5G 1X8, Canada

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Montreal, Quebec, H3H 1P3, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Paris, 75674, France

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Paris, 75935, France

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Bochum, 44797, Germany

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Osnabrück, 49074, Germany

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Potsdam, 14467, Germany

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Brescia, 25123, Italy

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Napoli, 80121, Italy

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Roma, 00161, Italy

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Rotterdam, 3015 GJ, Netherlands

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Bydgoszcz, 85-165, Poland

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Krakow, 33-663, Poland

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Lublin, 20-093, Poland

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Panorama, CPT, 7500, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3235, South Africa

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Durban, 3630, South Africa

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Overport, 4067, South Africa

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Pretoria, 0083, South Africa

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Zurich, 8032, Switzerland

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MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Australia, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, descresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 10, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 14, 2010
• Results First Posted: May 14, 2010

Record last verified: 2010-04

Locations

IT (3); AU (1); US (45); FR (2); CA (5); DE (3); NL (1); ZA (5); CH (1); PL (3); BE (2)