Gastroesophageal RefluxPhase 3NCT00365300

Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic 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 38 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

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD). Read more about this study

Who is it for?: Ages 28 days to 11 months
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: pantoprazole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 38 sitesUnited States
Study dates: Sep 2006to 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 28 days to 11 months
All sexes
No healthy volunteers
Child

Who may be able to join

term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
clinical diagnosis of GERD
weight greater than 2.5 kg and less than or equal to 15 kg

Who cannot join

known history of upper GI anatomic disorders
history of acute life-threatening medical conditions
clinically significant medical conditions or laboratory abnormalities

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Study site
Augusta, Georgia, 30912
Study site
Bardstown, Kentucky, 40004
Study site
Bethlehem, Pennsylvania, 18017
Study site
Boston, Massachusetts, 02114
Study site
Brooklyn, New York, 11219
Study site
Buffalo, New York, 14222
Study site
Burlington, Vermont, 05401
Study site
Camden, New Jersey, 08103
Study site
Cincinnati, Ohio, 45229
Study site
Durham, North Carolina, 27710
Study site
Flint, Michigan, 48503
Study site
Huntington, West Virginia, 25701
Study site
Jackson, Mississippi, 39216
Study site
Las Vegas, Nevada, 89109
Study site
Little Rock, Arkansas, 72205
Study site
Louisville, Kentucky, 40202
Study site
Madison, Wisconsin, 53715
Study site
Mays Landing, New Jersey, 08330
Study site
Memphis, Tennessee, 38103
Study site
Miami, Florida, 33101
Study site
Mobile, Alabama, 36604
Study site
Morgantown, West Virginia, 26506
Study site
Morristown, New Jersey, 07962
Study site
Norfolk, Virginia, 23507
Study site
Oakland, California, 94609
Study site
Oklahoma City, Oklahoma, 73104
Study site
Omaha, Nebraska, 68105
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32801
Study site
Pensacola, Florida, 32504
Study site
Peoria, Illinois, 61603
Study site
Phoenix, Arizona, 85016
Study site
Richmond, Virginia, 23219
Study site
Salt Lake City, Utah, 84113
Study site
Tampa, Florida, 33606
Study site
Temple, Texas, 76508
Study site
Valhalla, New York, 10595
Study site
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Conditions: Gastroesophageal Reflux
Being tested: pantoprazole, Placebo
Keywords: GERD, Infants, Gastroesophageal Reflux
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
PlaceboDrug

Study groups in NCT00365300
Study group	Role	What they receive
Pantoprazole	Active comparator	Not described Receives: Drug: pantoprazole
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
Measured: 4 weeks double-blind

Timeline

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

Sep 2006Nov 2007

First posted17 Aug 2006 (estimated)
Study startSep 2006
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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00365300
Sponsor's protocol ID: 3001B3-329
Status last verified: Apr 2010
First submitted: 16 Aug 2006
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
ClinicalTrials.gov ID: NCT00365300
Acronym / sponsor ID: 3001B3-329
Conditions: Gastroesophageal Reflux
Keywords: GERD, Infants, Gastroesophageal Reflux
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 17 Aug 2006 (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.

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pantoprazole	Active comparator	Drug: pantoprazole
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 28 days to 11 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
clinical diagnosis of GERD
weight greater than 2.5 kg and less than or equal to 15 kg

Key exclusion criteria (3 listed)

known history of upper GI anatomic disorders
history of acute life-threatening medical conditions
clinically significant medical conditions or laboratory 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	Drug	Pantoprazole
Placebo	Drug	Placebo

Primary outcome

Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Time frame: 4 weeks double-blind
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.

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
Pantoprazole Sodium Granules	129	107
Placebo	0	0

Primary outcome: Number of Patients Withdrawn From Study Due to Lack of Efficacy.

Time frame: 4 weeks double-blind. Number. Unit: patients

Measure	Pantoprazole Sodium Granules n = 52	Placebo n = 54
Value	6	6

Pantoprazole Sodium Granules vs Placebo: Risk Difference (RD): 0.004, p = 1.0, Fisher Exact

Population analysed: The analysis population was the Modified Intent to Treat, which included all GERD patients who completed the 4 week open-label treatment phase, were randomized into the 4 week double-blind phase, and took at least one dose of double-blind treatment.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening	2 of 129 (1.6%)	52 of 129 (40.3%)	Not reported
Pantoprazole Sodium Granules (Open-Label Phase)	4 of 128 (3.1%)	85 of 128 (66.4%)	Not reported
Pantoprazole Sodium Granules (Double-blind Phase)	0 of 54 (0%)	28 of 54 (51.9%)	Not reported
Placebo (Double-blind Phase)	1 of 54 (1.9%)	28 of 54 (51.9%)	Not reported
Follow-up	3 of 127 (2.4%)	25 of 127 (19.7%)	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

38 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 in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 38 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 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 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 38 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. Some participants in this study may receive a placebo. 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 Withdrawn From Study Due to Lack of Efficacy. (time frame: 4 weeks double-blind). 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 NCT00365300.

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.