Gastroesophageal RefluxPhase 3NCT00141817

Study Evaluating Pantoprazole in Children With GERD

A Phase 3 study testing pantoprazole for approximately 9 weeks. in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 23 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD. Read more about this study

Who is it for?: Ages 1 year to 11 years
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: pantoprazole for approximately 9 weeks.
How many people: 41 participants
Where: 23 sitesUnited States
Study dates: Aug 2005to Nov 2007
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 year to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Endoscopically proven GERD diagnosed within 6 months before study entry.
Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Who cannot join

History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
Subjects 6-11 years old unable to swallow tablets

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02115
Study site
Brockton, Massachusetts, 02302
Study site
Cincinnati, Ohio, 45229
Study site
Detroit, Michigan, 48201
Study site
Flint, Michigan, 48503
Study site
Gainesville, Florida, 32610
Study site
Indianapolis, Indiana, 46202
Study site
Jackson, Mississippi, 39216
Study site
Kansas City, Missouri, 64108
Study site
Little Rock, Arkansas, 72205
Study site
Louisville, Kentucky, 40202
Study site
Memphis, Tennessee, 38105
Study site
Miami, Florida, 33101
Study site
Milwaukee, Wisconsin, 53226
Study site
New York, New York, 10032
Study site
Orange, California, 92868
Study site
Park Ridge, Illinois, 60068
Study site
Pensacola, Florida, 32504
Study site
Salt Lake City, Utah, 84108
Study site
San Diego, California, 92103
Study site
Temple, Texas, 76508
Study site
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Conditions: Gastroesophageal Reflux
Being tested: pantoprazole for approximately 9 weeks.
Keywords: Gastrointestinal Reflux Disease
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 for approximately 9 weeks.Drug

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Apparent Oral Clearance (CL/F)
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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Terminal-Phase Volume of Distribution (Vz/F)
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Measured: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma Concentrations After Multiple Doses
Measured: Hours 2 and 4 on Day 7

Timeline

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

Aug 2005Nov 2007

First posted1 Sep 2005 (estimated)
Study startAug 2005
Primary completionNov 2007
Study completionNov 2007

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: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00141817
Sponsor's protocol ID: 3001B3-334
Other IDs: B1791059
Status last verified: Nov 2011
First submitted: 30 Aug 2005
Last updated: 28 Dec 2011
Results posted: Yes, on ClinicalTrials.gov

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

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease

All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2011. 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 Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD
ClinicalTrials.gov ID: NCT00141817
Acronym / sponsor ID: 3001B3-334
Conditions: Gastroesophageal Reflux
Keywords: Gastrointestinal Reflux Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 1 Sep 2005 (estimated)
Results: Posted 28 Dec 2011

Clinical summary

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

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Endoscopically proven GERD diagnosed within 6 months before study entry.
Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Key exclusion criteria (2 listed)

History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
Subjects 6-11 years old unable to swallow tablets

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 for approximately 9 weeks.	Drug	–

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Plasma Decay Half-Life (t1/2)
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Terminal-Phase Volume of Distribution (Vz/F)
Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Plasma Concentrations After Multiple Doses
Time frame: Hours 2 and 4 on Day 7

Results and safety

Results posted to the registry on 28 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pantoprazole 0.6 mg/kg Spheroids	7	6
Pantoprazole 1.2 mg/kg Spheroids	10	10
Pantoprazole 0.6 mg/kg Tablets	11	10
Pantoprazole 1.2 mg/kg Tablets	13	13

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	Pantoprazole 0.6 mg/kg Spheroids n = 3	Pantoprazole 1.2 mg/kg Spheroids n = 7	Pantoprazole 0.6 mg/kg Tablets n = 10	Pantoprazole 1.2 mg/kg Tablets n = 13
Value	136 (127)	798 (729)	1643 (1229)	2067 (1320)

Population analysed: Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose. Mean (Standard Deviation). Unit: hours

Measure	Pantoprazole 0.6 mg/kg Spheroids n = 3	Pantoprazole 1.2 mg/kg Spheroids n = 7	Pantoprazole 0.6 mg/kg Tablets n = 10	Pantoprazole 1.2 mg/kg Tablets n = 12
Value	1.45 (0.69)	2.71 (1.25)	2.08 (0.75)	2.03 (0.74)

Population analysed: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose. Mean (Standard Deviation). Unit: nanogram hour per milliliter (ng*h/mL)

Measure	Pantoprazole 0.6 mg/kg Spheroids n = 3	Pantoprazole 1.2 mg/kg Spheroids n = 7	Pantoprazole 0.6 mg/kg Tablets n = 10	Pantoprazole 1.2 mg/kg Tablets n = 13
Value	208.96 (197.54)	2273.96 (1885.68)	2448.61 (2007.21)	3190.96 (2137.91)

Population analysed: Single-Dose Valid-for-Evaluation Population.

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Pantoprazole 0.6 mg/kg Spheroids n = 3	Pantoprazole 1.2 mg/kg Spheroids n = 7	Pantoprazole 0.6 mg/kg Tablets n = 10	Pantoprazole 1.2 mg/kg Tablets n = 11
Value	293.29 (146.41)	2448.08 (2170.48)	2497.13 (2099.64)	3782.49 (1837.42)

Population analysed: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pantoprazole 0.6 mg/kg Spheroids	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Pantoprazole 1.2 mg/kg Spheroids	0 of 10 (0%)	7 of 10 (70%)	Not reported
Pantoprazole 0.6 mg/kg Tablets	0 of 11 (0%)	9 of 11 (81.8%)	Not reported
Pantoprazole 1.2 mg/kg Tablets	0 of 13 (0%)	7 of 13 (53.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
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

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease

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

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pantoprazole for approximately 9 weeks. in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 23 sites in United States.

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 2 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 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. 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 28 Dec 2011). 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?

Maximum Observed Plasma Concentration (Cmax) (time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose). The study lists 8 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 NCT00141817, 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 28 Dec 2011.