Gastroesophageal RefluxPhase 3NCT00362609
Study Evaluating Pantoprazole in Neonates and Preterm Infants With 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.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- 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
- 59 participants
- Where
- 71 sitesin 11 countries
- Study dates
- Jul 2006to Dec 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
Trial locations and contacts
71 sites in 11 countries.
71 sites in 11 countries
United States45 sites
Study site
Albany, New York, 12208
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21201
Study site
Boise, Idaho, 83704
Study site
Boston, Massachusetts, 02114
Study site
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
Study site
Morgantown, West Virginia, 26506
Study site
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
Study site
Newark, New Jersey, 07103
Study site
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
Study site
Valhalla, New York, 10595-1689
Study site
Washington D.C., District of Columbia, 20010
Study site
Winston-Salem, North Carolina, 27157
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
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
Germany3 sites
Study site
Bochum, 44797
Study site
Osnabrück, 49074
Study site
Potsdam, 14467
Italy3 sites
Study site
Brescia, 25123
Study site
Naples, 80121
Study site
Roma, 00161
Poland3 sites
Study site
Bydgoszcz, 85-165
Study site
Krakow, 33-663
Study site
Lublin, 20-093
About this study
Official title: A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
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
- 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 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.
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.
Measured: 1 day
Secondary outcomes (3)
Area Under the Concentration-time Curve (AUC)
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.
Measured: Baseline to 24 hours post dose on Day 1
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.
Measured: 1 day
Half Life
Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 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.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.comTrial Manager, Principal investigator, For Germany, medinfoDEU@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Manager, Principal investigator, For Poland, WPWZMED@wyeth.comTrial Manager, Principal investigator, For South Africa, ZAFinfo@wyeth.comTrial Manager, Principal investigator, For Australia, medinfo@wyeth.comTrial Manager, Principal investigator, For France, infomedfrance@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362609
- Sponsor's protocol ID
- 3001B3-331, 3001B3-335
- Status last verified
- Apr 2010
- First submitted
- 8 Aug 2006
- Last updated
- 14 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
- ClinicalTrials.gov ID
- NCT00362609
- Acronym / sponsor ID
- 3001B3-331, 3001B3-335
- Conditions
- Gastroesophageal Reflux
- Keywords
- Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 14 May 2010
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 determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
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 |
| High dose | Active comparator | Drug: pantoprazole |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
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
Variance of Oral Bioavailability
Time frame: 1 day
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.
3 secondary outcomes
Area Under the Concentration-time Curve (AUC)
Time frame: Baseline to 24 hours post dose on Day 1
Apparent Oral Clearance (Cl/F)
Time frame: 1 day
Half Life
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RETHINK REFLUX Registry
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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 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 3 inclusion and 3 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 14 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 14 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?
Variance of Oral Bioavailability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2010.