Trial · NCT00373334

Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)

NCT00373334, Phase 3, Completed, Braintree Laboratories; results first posted 2009-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD). Trials, record NCT00373334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00373334

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Trial

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

Title: Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
NCT number: NCT00373334
Status: Completed
Phases: Phase 3
Enrollment: 138 participants, actual
Lead sponsor: Braintree Laboratories
Conditions: Gastroesophageal Reflux Disease, GERD, Heartburn
Interventions: nizatidine (axid), nizatidine (axid), placebo
First posted: 2006-09-08
Last updated: 2009-11-18
Results first posted: 2009-11-17

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	8 weeks	The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.
Secondary	Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	8 weeks	Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.
Secondary	Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity	8 weeks	Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	8 weeks	The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.	participants	NUMBER
SECONDARY	Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	8 weeks	The analysis population includes all patients that took drug and reached the 8 week study timepoint.	participants	NUMBER
SECONDARY	Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity	8 weeks	The analysis population includes all patients that took drug and reached the 8 week study timepoint.	participants	NUMBER

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Units
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	Nizatidine 2.5 mg/kg b.i.d.		27	participants
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	Nizatidine 5.0 mg/kg b.i.d.		32	participants
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	Conservative Measures Only		31	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Nizatidine 2.5 mg/kg b.i.d.	Better	32	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Nizatidine 5.0 mg/kg b.i.d.	Better	36	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Conservative Measures Only	Better	29	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Nizatidine 2.5 mg/kg b.i.d.	No Change	4	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Nizatidine 5.0 mg/kg b.i.d.	No Change	2	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Conservative Measures Only	No Change	6	participants
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Nizatidine 2.5 mg/kg b.i.d.	Worse	5	participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nizatidine 2.5 mg/kg Twice Daily	43
Overall Study	STARTED	Nizatidine 5.0 mg/kg Twice Daily	50
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Nizatidine 2.5 mg/kg Twice Daily	33
Overall Study	COMPLETED	Nizatidine 5.0 mg/kg Twice Daily	32
Overall Study	COMPLETED	Placebo	32
Overall Study	NOT COMPLETED	Nizatidine 2.5 mg/kg Twice Daily	10
Overall Study	NOT COMPLETED	Nizatidine 5.0 mg/kg Twice Daily	18
Overall Study	NOT COMPLETED	Placebo	13

Source ClinicalTrials.gov

Adverse events36

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	Diarrhea	Gastrointestinal disorders	Nizatidine 2.5 mg/kg b.i.d.	4	43
other	Diarrhea	Gastrointestinal disorders	Nizatidine 5.0 mg/kg b.i.d.	4	50
other	Diarrhea	Gastrointestinal disorders	Conservative Measures Only	5	45
other	Pyrexia	General disorders	Nizatidine 2.5 mg/kg b.i.d.	6	43
other	Pyrexia	General disorders	Nizatidine 5.0 mg/kg b.i.d.	1	50
other	Pyrexia	General disorders	Conservative Measures Only	3	45
other	Teething	Gastrointestinal disorders	Nizatidine 2.5 mg/kg b.i.d.	4	43
other	Teething	Gastrointestinal disorders	Nizatidine 5.0 mg/kg b.i.d.	3	50
other	Teething	Gastrointestinal disorders	Conservative Measures Only	3	45
other	bronchiolitis	Infections and infestations	Nizatidine 2.5 mg/kg b.i.d.	3	43

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nizatidine 2.5 mg/kg b.i.d.
Total, all-cause mortality	Nizatidine 5.0 mg/kg b.i.d.
Total, all-cause mortality	Conservative Measures Only
Total, other adverse events	Nizatidine 2.5 mg/kg b.i.d.	27	43
Total, other adverse events	Nizatidine 5.0 mg/kg b.i.d.	31	50
Total, other adverse events	Conservative Measures Only	31	45
Total, serious adverse events	Nizatidine 2.5 mg/kg b.i.d.	0	43
Total, serious adverse events	Nizatidine 5.0 mg/kg b.i.d.	0	50
Total, serious adverse events	Conservative Measures Only	1	45

Source ClinicalTrials.gov

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.

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GET https://conductscience.org/api/trials/v1/NCT00373334/results?page=2

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