Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
19. april 2010 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer
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
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
67
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brisbane, Australien
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Antwerpen, Belgien, B-2020
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Brussels, Belgien, B-1090
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Gent, Belgien, B-9000
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Loma Linda, California, Forenede Stater, 92351
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San Diego, California, Forenede Stater, 92103
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
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Florida
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Miami, Florida, Forenede Stater, 33101
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Pensacola, Florida, Forenede Stater, 32504
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Illinois
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Chicago, Illinois, Forenede Stater, 60614
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Park Ridge, Illinois, Forenede Stater, 60068
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71130
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
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New York
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New York, New York, Forenede Stater, 10032
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
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Texas
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Temple, Texas, Forenede Stater, 76508
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Paris, Frankrig, 75674
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Brescia, Italien, 25123
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Naples, Italien, 80131
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Roma, Italien, 00161
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Krakow, Polen, 30-663
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Lodz, Polen, 91-738
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Lublin, Polen
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Warszaw, Polen, 04-730
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Zurich, Schweiz, 8032
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Aachen, Tyskland, D-52074
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Osnabruck, Tyskland, D-49074
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 11 måneder (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Høj dosis
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pediatric suspension taken daily x 7 days
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Aktiv komparator: Lav dosis
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pediatric suspension taken daily x 7 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Peak Concentration (Cmax)
Tidsramme: 1 day
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Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
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1 day
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Time to Peak Concentration (Tmax) Profile
Tidsramme: 1 day
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Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
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1 day
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Disposition Half-life
Tidsramme: 1 day
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Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole.
Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.
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1 day
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Area Under the Concentration-time Curve (AUC)
Tidsramme: 1 day
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Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole.
AUC is a measure of the plasma concentration of the drug over time.
It is used to characterize drug absorption.
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1 day
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Apparent Oral Clearance (CL/F)
Tidsramme: 1 day
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Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
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1 day
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Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Tidsramme: 7 days
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Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
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7 days
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Intragastric pH
Tidsramme: 7 days
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Intragastric pH is a method for evaluating gastric acidity scaled 0-9.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Median Intragastric pH
Tidsramme: 7 days
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Intragastric pH is a method for evaluating gastric acidity scaled 0-9.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Percentage of Time Intragastric pH Was >4
Tidsramme: 7 days
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Intragastric pH is a method for evaluating gastric acidity.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Mean Intraesophageal pH
Tidsramme: 7 days
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Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Median Intraesophageal pH
Tidsramme: 7 days
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Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Percentage of Time That Intraesophageal pH Was <4
Tidsramme: 7 days
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Intraesophagel pH is a method for evaluating acidity of gastric refluxate.
A lower pH means more acidity.
A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
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7 days
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Normalized Area of Gastric Hydrogen Ion Activity Over Time
Tidsramme: 7 days
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Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.
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7 days
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Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Tidsramme: 7 days
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Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.
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7 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Trial Manager, For Australia, medinfo@wyeth.com
- Ledende efterforsker: Trial Manager, For Poland, WPWZMED@wyeth.com
- Ledende efterforsker: Trial Manager, For Switzerland, med@wyeth.com
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2005
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
23. november 2005
Først indsendt, der opfyldte QC-kriterier
23. november 2005
Først opslået (Skøn)
28. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. maj 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2010
Sidst verificeret
1. april 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3001B3-333, 3001B3-335
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .