Trial · NCT00365300

Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

NCT00365300, Phase 3, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2010-01-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD). Trials, record NCT00365300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365300

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT number: NCT00365300
Status: Completed
Phases: Phase 3
Enrollment: 129 participants, actual
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Conditions: Gastroesophageal Reflux
Interventions: pantoprazole, Placebo
First posted: 2006-08-17
Last updated: 2010-05-04
Results first posted: 2010-01-07

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients Withdrawn From Study Due to Lack of Efficacy.	4 weeks double-blind	Lack of efficacy defined as 1 or more of the following occurring during the double blind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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients Withdrawn From Study Due to Lack of Efficacy.	4 weeks double-blind	The analysis population was the Modified Intent to Treat, which included all GERD patients who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.	patients	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Patients Withdrawn From Study Due to Lack of Efficacy.	Pantoprazole Sodium Granules		6		patients
Number of Patients Withdrawn From Study Due to Lack of Efficacy.	Placebo		6		patients

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open-label Phase	STARTED	Pantoprazole Sodium Granules	129
Open-label Phase	STARTED	Placebo	0
Open-label Phase	COMPLETED	Pantoprazole Sodium Granules	107
Open-label Phase	COMPLETED	Placebo	0
Open-label Phase	NOT COMPLETED	Pantoprazole Sodium Granules	22
Open-label Phase	NOT COMPLETED	Placebo	0
Double-blind Phase	STARTED	Pantoprazole Sodium Granules	54
Double-blind Phase	STARTED	Placebo	54
Double-blind Phase	COMPLETED	Pantoprazole Sodium Granules	43
Double-blind Phase	COMPLETED	Placebo	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events385

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Accidental injury	General disorders	Screening	1	129
other	Accidental injury	General disorders	Pantoprazole Sodium Granules (Open-Label Phase)	1	128
other	Accidental injury	General disorders	Pantoprazole Sodium Granules (Double-blind Phase)	1	54
other	Accidental injury	General disorders	Placebo (Double-blind Phase)	2	54
other	Accidental injury	General disorders	Follow-up	1	127
other	Fever	General disorders	Screening	10	129
other	Fever	General disorders	Pantoprazole Sodium Granules (Open-Label Phase)	15	128
other	Fever	General disorders	Pantoprazole Sodium Granules (Double-blind Phase)	3	54
other	Fever	General disorders	Placebo (Double-blind Phase)	2	54
other	Fever	General disorders	Follow-up	0	127

1 to 10 of 385Source ClinicalTrials.gov

See all 385 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Screening
Total, all-cause mortality	Pantoprazole Sodium Granules (Open-Label Phase)
Total, all-cause mortality	Pantoprazole Sodium Granules (Double-blind Phase)
Total, all-cause mortality	Placebo (Double-blind Phase)
Total, all-cause mortality	Follow-up
Total, other adverse events	Screening	52	129
Total, other adverse events	Pantoprazole Sodium Granules (Open-Label Phase)	85	128
Total, other adverse events	Pantoprazole Sodium Granules (Double-blind Phase)	28	54
Total, other adverse events	Placebo (Double-blind Phase)	28	54
Total, other adverse events	Follow-up	25	127

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00365300

GET https://conductscience.org/api/trials/v1/NCT00365300/events?page=2

API reference For AI assistants