Gastroesophageal RefluxPhase 3NCT00259012

Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

A Phase 3 study testing pantoprazole sodium enteric-coated spheroid suspension in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 31 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 month to 11 months
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: pantoprazole sodium enteric-coated spheroid suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 31 sitesin 8 countries
Study dates: Nov 2005to Mar 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 11 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
Clinically significant medical or surgical abnormalities

Trial locations and contacts

31 sites in 8 countries.

Country

City, postcode or hospital

31 sites in 8 countries

United States16 sites

Study site
Chicago, Illinois, 60614
Study site
Cleveland, Ohio, 44106
Study site
Durham, North Carolina, 27710
Study site
Jackson, Mississippi, 39216
Study site
Kansas City, Missouri, 64108
Study site
Little Rock, Arkansas, 72205
Study site
Loma Linda, California, 92351
Study site
Louisville, Kentucky, 40202
Study site
Miami, Florida, 33101
Study site
New York, New York, 10032
Study site
Park Ridge, Illinois, 60068
Study site
Pensacola, Florida, 32504
Study site
San Diego, California, 92103
Study site
Shreveport, Louisiana, 71130
Study site
Temple, Texas, 76508
Study site
Washington D.C., District of Columbia, 20010

Other trials in United States

Poland4 sites

Study site
Krakow, 30-663
Study site
Lodz, 91-738
Study site
Lublin
Study site
Warsaw, 04-730

Other trials in Poland

Belgium3 sites

Study site
Antwerp, B-2020
Study site
Brussels, B-1090
Study site
Ghent, B-9000

Other trials in Belgium

Italy3 sites

Study site
Brescia, 25123
Study site
Naples, 80131
Study site
Roma, 00161

Other trials in Italy

Germany2 sites

Study site
Aachen, D-52074
Study site
Osnabrück, D-49074

Other trials in Germany

Australia1 site

Study site
Brisbane

Other trials in Australia

France1 site

Study site
Paris, 75674

Other trials in France

Switzerland1 site

Study site
Zurich, 8032

Other trials in Switzerland

About this 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

Conditions: Gastroesophageal Reflux
Being tested: pantoprazole sodium enteric-coated spheroid suspension
Keywords: GERD, Infant
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pantoprazole sodium enteric-coated spheroid suspensionDrug
pediatric suspension taken daily x 7 days

Study groups in NCT00259012
Study group	Role	What they receive
Low dose	Active comparator	Not described Receives: Drug: pantoprazole sodium enteric-coated spheroid suspension
High dose	Active comparator	Not described Receives: Drug: pantoprazole sodium enteric-coated spheroid suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Concentration (Cmax)
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Measured: 1 day
Time to Peak Concentration (Tmax) Profile
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Measured: 1 day
Disposition Half-life
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.
Measured: 1 day
Area Under the Concentration-time Curve (AUC)
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.
Measured: 1 day
Apparent Oral Clearance (CL/F)
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.
Measured: 1 day
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Measured: 7 days
Intragastric pH
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).
Measured: 7 days
Median Intragastric pH
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).
Measured: 7 days
Percentage of Time Intragastric pH Was >4
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).
Measured: 7 days
Mean Intraesophageal pH
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).
Measured: 7 days
Median Intraesophageal pH
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).
Measured: 7 days
Percentage of Time That Intraesophageal pH Was <4
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).
Measured: 7 days
Normalized Area of Gastric Hydrogen Ion Activity Over Time
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.
Measured: 7 days
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
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.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Mar 2008

First posted28 Nov 2005 (estimated)
Study startNov 2005
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00259012
Sponsor's protocol ID: 3001B3-333, 3001B3-335
Status last verified: Apr 2010
First submitted: 23 Nov 2005
Last updated: 7 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.
PubMed 21740077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00259012
Acronym / sponsor ID: 3001B3-333, 3001B3-335
Conditions: Gastroesophageal Reflux
Keywords: GERD, Infant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Collaborators: Nycomed
Study start: Nov 2005
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 28 Nov 2005 (estimated)
Results: Posted 7 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low dose	Active comparator	Drug: pantoprazole sodium enteric-coated spheroid suspension
High dose	Active comparator	Drug: pantoprazole sodium enteric-coated spheroid suspension

Who may qualify

Ages: 1 month to 11 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
Clinically significant medical or surgical abnormalities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pantoprazole sodium enteric-coated spheroid suspensionpediatric suspension taken daily x 7 days	Drug	High dose, Low dose

Primary outcome

Peak Concentration (Cmax)
Time frame: 1 day
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Time to Peak Concentration (Tmax) Profile
Time frame: 1 day
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Disposition Half-life
Time frame: 1 day
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.
Area Under the Concentration-time Curve (AUC)
Time frame: 1 day
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.
Apparent Oral Clearance (CL/F)
Time frame: 1 day
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.
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Time frame: 7 days
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Intragastric pH
Time frame: 7 days
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).
Median Intragastric pH
Time frame: 7 days
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).
Percentage of Time Intragastric pH Was >4
Time frame: 7 days
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).
Mean Intraesophageal pH
Time frame: 7 days
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).
Median Intraesophageal pH
Time frame: 7 days
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).
Percentage of Time That Intraesophageal pH Was <4
Time frame: 7 days
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).
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Time frame: 7 days
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.
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Time frame: 7 days
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.

Results and safety

Results posted to the registry on 7 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Pantoprazole (0.6 mg/kg)	33	31
High Dose Pantoprazole (1.2 mg/kg)	34	30

Primary outcome: Peak Concentration (Cmax)

Time frame: 1 day. Mean (Standard Deviation). Unit: ng/mL

Measure	Low Dose Pantoprazole (0.6 mg/kg) n = 17	High Dose Pantoprazole (1.2 mg/kg) n = 18
Value	567 (534)	1527 (1298)

Population analysed: All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.

Primary outcome: Time to Peak Concentration (Tmax) Profile

Time frame: 1 day. Median (Full Range). Unit: hr

Measure	Low Dose Pantoprazole (0.6 mg/kg) n = 17	High Dose Pantoprazole (1.2 mg/kg) n = 18
Value	1.03 (1.00 to 4.00)	1.02 (0.50 to 4.08)

Primary outcome: Disposition Half-life

Time frame: 1 day. Mean (Standard Deviation). Unit: hr

Measure	Low Dose Pantoprazole (0.6 mg/kg) n = 17	High Dose Pantoprazole (1.2 mg/kg) n = 18
Value	1.78 (1.30)	1.42 (0.78)

Primary outcome: Area Under the Concentration-time Curve (AUC)

Time frame: 1 day. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Low Dose Pantoprazole (0.6 mg/kg) n = 17	High Dose Pantoprazole (1.2 mg/kg) n = 18
Value	1046 (1043)	3602 (3269)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Pantoprazole (0.6 mg/kg)	3 of ?	13 of ?	Not reported
High Dose Pantoprazole (1.2 mg/kg)	2 of ?	17 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21740077Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.

Related trials for Gastroesophageal Reflux

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Australia, medinfo@wyeth.com

Trial Manager principal investigator

For Belgium, trials-BEL@wyeth.com

31 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Poland, Belgium, Italy, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Concentration (Cmax) (time frame: 1 day). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00259012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.