Gastroesophageal RefluxPhase 3NCT00868296

Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

A Phase 3 study testing pantoprazole in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 71 sites in 11 countries.

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 provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study. Read more about this study

Who is it for?: Ages 1 day to 12 months
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: pantoprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 71 sitesin 11 countries
Study dates: Mar 2006to 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 day to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

Who cannot join

Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Trial locations and contacts

71 sites in 11 countries.

Country

City, postcode or hospital

71 sites in 11 countries

United States45 sites

Study site
Albany, New York, 12208
Study site
Atlanta, Georgia, 30322
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Baltimore, Maryland, 21201
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Boise, Idaho, 83704
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Boston, Massachusetts, 02114
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Brooklyn, New York, 11219
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Burlington, Vermont, 05401
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Camden, New Jersey, 08103
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Chicago, Illinois, 60614
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Dallas, Texas, 75390-9063
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Danville, Pennsylvania, 17822-1320
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Durham, North Carolina, 27710
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Flint, Michigan, 48503
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Gainesville, Florida, 32610-0296
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Honolulu, Hawaii, 96826
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Lexington, Kentucky, 40536-0284
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Loma Linda, California, 92354
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Louisville, Kentucky, 40202
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Memphis, Tennessee, 38163
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Miami, Florida, 33101
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Milwaukee, Wisconsin, 53226
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Morgantown, West Virginia, 26506
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Nashville, Tennessee, 37232-9550
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New Brunswick, New Jersey, 08901
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New Haven, Connecticut, 06520-8064
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New Orleans, Louisiana, 70121
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New York, New York, 10032
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Newark, New Jersey, 07103
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Oakland, California, 94609-1809
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Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68105
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Orange, California, 92868
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Park Ridge, Illinois, 60068
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Phoenix, Arizona, 85006
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Portland, Oregon, 97239-3042
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Richmond, Virginia, 23298
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Sacramento, California, 95817
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Salt Lake City, Utah, 84113
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San Antonio, Texas, 78229
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San Diego, California, 92103
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Sunrise, Florida, 33323
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The Bronx, New York, 10467
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Valhalla, New York, 10595-1689
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Washington D.C., District of Columbia, 20010
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Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

Study site
Montreal, Quebec, H3H 1P3
Study site
Ottawa, Ontario, K1Y 4E9
Study site
Sainte-Foy, Quebec, G1V 4G2
Study site
Toronto, Ontario, M5G 1X8
Study site
Vancouver, British Columbia, V6H 3V4

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South Africa5 sites

Study site
Durban, 3630
Study site
Overport, 4067
Study site
Panorama, CPT, 7500
Study site
Pietermaritzburg, KwaZulu-Natal, 3235
Study site
Pretoria, 0083

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Germany3 sites

Study site
Bochum, 44797
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Osnabrück, 49074
Study site
Potsdam, 14467

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Italy3 sites

Study site
Brescia, 25123
Study site
Naples, 80121
Study site
Roma, 00161

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Poland3 sites

Study site
Bydgoszcz, 85-165
Study site
Krakow, 33-663
Study site
Lublin, 20-093

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Belgium2 sites

Study site
Edegem, 2650
Study site
Leuven, 3000

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France2 sites

Study site
Paris, 75674
Study site
Paris, 75935

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Australia1 site

Study site
Brisbane

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Netherlands1 site

Study site
Rotterdam, 3015 GJ

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Switzerland1 site

Study site
Zurich, 8032

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About this study

Official title: A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

Conditions: Gastroesophageal Reflux
Being tested: pantoprazole
Keywords: Safety
Medical subject headings: Gastroesophageal Reflux

What participants receive

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

pantoprazoleDrug

Study groups in NCT00868296
Study group	Role	What they receive
Low dose	Active comparator	Not described Receives: Drug: pantoprazole
High dose	Active comparator	Not described Receives: Drug: pantoprazole

What is being measured

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

Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.
Measured: 6 weeks
Growth Parameters Z-scores
Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Measured: 6 weeks

Timeline

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

Mar 2006Mar 2008

First posted24 Mar 2009 (estimated)
Study startMar 2006
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.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00868296
Sponsor's protocol ID: 3001B3-335
Status last verified: Apr 2010
First submitted: 20 Mar 2009
Last updated: 4 May 2010
Results posted: Yes, on ClinicalTrials.gov

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

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
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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

All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD
ClinicalTrials.gov ID: NCT00868296
Acronym / sponsor ID: 3001B3-335
Conditions: Gastroesophageal Reflux
Keywords: Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 24 Mar 2009 (estimated)
Results: Posted 7 Jan 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low dose	Active comparator	Drug: pantoprazole
High dose	Active comparator	Drug: pantoprazole

Who may qualify

Ages: 1 day to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

Key exclusion criteria (1 listed)

Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

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	Drug	High dose, Low dose

Primary outcome

Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period
Time frame: 6 weeks
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.
Growth Parameters Z-scores
Time frame: 6 weeks
Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Results and safety

Results posted to the registry on 7 Jan 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	12	12
High Dose Pantoprazole	46	43

Primary outcome: Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period

Time frame: 6 weeks. Number. Unit: patients

Measure	Low Dose Pantoprazole n = 12	High Dose Pantoprazole n = 45
Potassium (mmol/L)	0	3
Carbon dioxide (mmol/L)	0	1
Total bilirubin (µmol/L)	0	1
CPK (mU/mL)	0	2
Gastrin (pg/mL)	0	1
Neutrophils (1,000,000,000/L)	1	0
Platelet count (1,000,000,000/L)	0	2
Urine protein albumin	0	1

Population analysed: Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38).

Primary outcome: Growth Parameters Z-scores

Time frame: 6 weeks. Mean (Standard Deviation). Unit: units on scale

Measure	Low Dose Pantoprazole n = 12	High Dose Pantoprazole n = 46
Length - Baseline (n=12, 45)	0.33 (1.11)	-1.63 (2.99)
Length - Final evaluation (n=12, 45)	0.45 (1.29)	-1.04 (2.52)
Weight - Baseline (n=12, 46)	-0.16 (1.15)	-1.26 (1.90)
Weight - Final evaluation (n=12, 46)	-0.05 (1.33)	-1.00 (1.73)
Head circumference - Baseline (n=11, 45)	0.31 (1.17)	-1.06 (2.10)
Head circumference - Final evaluation (n=11, 45)	0.25 (1.21)	-0.62 (1.71)

Low Dose Pantoprazole vs High Dose Pantoprazole: p = 0.857, ANCOVA
Low Dose Pantoprazole vs High Dose Pantoprazole: p = 0.901, ANCOVA
Low Dose Pantoprazole vs High Dose Pantoprazole: p = 0.807, ANCOVA

Population analysed: Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Pantoprazole	1 of ?	8 of ?	Not reported
High Dose Pantoprazole	2 of ?	30 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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

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 Belgium, trials-BEL@wyeth.com

Trial Manager principal investigator

For Germany, medinfoDEU@wyeth.com

71 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pantoprazole in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 71 sites in 11 countries.

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 1 inclusion and 1 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 4 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 71 sites in United States, Canada, South Africa, Germany, Italy and 6 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 Jan 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?

Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period (time frame: 6 weeks). The study lists 2 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 NCT00868296.

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 4 May 2010; AzTrials last refreshed its copy on 7 Nov 2026.