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

ClinicalTrials.gov ID: NCT00373334

Public ClinicalTrials.gov record NCT00373334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Randomized, Parallel, Multicenter Study of Axid (Nizatidine) Oral Solution in the Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms in Infants Age 30 Days-1 Year

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.

Study identification

NCT ID: NCT00373334
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Braintree Laboratories; Industry
Enrollment: 138 participants

Conditions and interventions

Conditions

Interventions

nizatidine (axid) Drug
placebo Drug

Drug

Eligibility (public fields only)

Age range: 30 Days to 1 Year
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2006 (Type not available)
Primary completion: Feb 2008 (Actual)
Completion: Feb 2008 (Actual)
Last update posted: Nov 18, 2009

2006 – 2008

United States locations

U.S. sites: 26
U.S. states: 14
U.S. cities: 25

Facility	City	State	ZIP	Site status
Not listed	Hot Springs	Arkansas	71913	—
Not listed	Jonesboro	Arkansas	72401	—
Not listed	Little Rock	Arkansas	72205	—
Not listed	Little Rock	Arkansas	72211	—
Not listed	Searcy	Arkansas	—	—
Not listed	Madiera	California	—	—
Not listed	Centennial	Colorado	80112	—
Not listed	Orlando	Florida	—	—
Not listed	Panama City	Florida	32405	—
Not listed	Tampa	Florida	33603	—
Not listed	Tifton	Georgia	—	—
Not listed	Owensboro	Kentucky	42303	—
Not listed	Shreveport	Louisiana	71105	—
Not listed	Lincoln	Nebraska	68505	—
Not listed	Bismarck	North Dakota	58501	—
Not listed	Fargo	North Dakota	58103	—
Not listed	Fairfield	Ohio	45014	—
Not listed	Mason	Ohio	45040	—
Not listed	Hershey	Pennsylvania	—	—
Not listed	Pittsburgh	Pennsylvania	15202	—
Not listed	Clarksville	Tennessee	37043	—
Not listed	Houston	Texas	77004	—
Not listed	Missouri City	Texas	77495	—
Not listed	Temple	Texas	76502	—
Not listed	Ogden	Utah	84405	—
Not listed	South Jordan	Utah	84095	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00373334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 18, 2009 · Synced Oct 24, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00373334 live on ClinicalTrials.gov.

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