Gastroesophageal Reflux DiseasePhase 3NCT00373334

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

A Phase 3 study testing nizatidine (axid) in people with Gastroesophageal Reflux Disease and GERD, run by Braintree Laboratories at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 30 days to 1 year
Conditions the study is for: Gastroesophageal Reflux Disease, GERD, Heartburn
What is being tested?: nizatidine (axid)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 26 sitesUnited States
Study dates: Aug 2006to Feb 2008
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 30 days to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatients age 30 days up to 1 year at Visit 1.
Subjects must have a documented medical diagnosis of gastroesophageal reflux disease (GERD), confirmed by either endoscopy or pH monitoring, or by evaluation of baseline symptoms.
Subjects must be greater than the 3rd percentile of weight and height for their age.
Parents/guardians are competent and willing to provide consent and sign and date the institutional review board (IRB) approved consent form.
Parents/guardians are willing to adhere to study requirements, including applying the conservative GERD management methods.
Conservative GERD management methods have failed to adequately control GERD symptoms by Visit 2.
Parent/guardian and infant live in the same household.
Qualifying caregiver questionnaire score at Visits 1 \& 2.

Who cannot join

Any known esophageal disease or disorder, other than reflux esophagitis.
Any active gastroduodenal ulceration, or clinical or endoscopic evidence of active gastrointestinal bleeding.
Any prior esophageal or gastric surgery.
Concurrent serious systemic disorders, including chronic respiratory disease, chronic neurologic disease, chronic renal disease, chronic liver disease.
Subjects with clinically significant abnormal laboratory findings at screening.
Premature infants < 37 weeks gestation at birth.

Show all 15Show fewer

Infants with prior neonatal intensive care unit admission for any reason.
Hematemesis or apparent life-threatening events (ALTE).
Concurrent treatment with any chronic medication except by permission of the study sponsor.
Treatment with a histamine 2 receptor antagonist (H2RA), antacid, sucralfate, prostaglandin, or motility agent within 3 days before Visit 1; treatment with a proton pump inhibitor within 7 days before Visit 1.
Requirement or likely requirement for a medical procedure or surgery during the study.
Known hypersensitivity to an H2RA including nizatidine.
Receipt of any investigational agent within the previous 30 days before randomization.
Poor medical or psychiatric risks for therapy with an investigational drug, in the opinion of the investigator.
Any condition in parent/guardian associated with poor subject compliance e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Study site
Bismarck, North Dakota, 58501
Study site
Centennial, Colorado, 80112
Study site
Clarksville, Tennessee, 37043
Study site
Fairfield, Ohio, 45014
Study site
Fargo, North Dakota, 58103
Study site
Hershey, Pennsylvania
Study site
Hot Springs, Arkansas, 71913
Study site
Houston, Texas, 77004
Study site
Jonesboro, Arkansas, 72401
Study site
Lincoln, Nebraska, 68505
Study site
Little Rock, Arkansas, 72205
Study site
Little Rock, Arkansas, 72211
Study site
Madiera, California
Study site
Mason, Ohio, 45040
Study site
Missouri City, Texas, 77495
Study site
Ogden, Utah, 84405
Study site
Orlando, Florida
Study site
Owensboro, Kentucky, 42303
Study site
Panama City, Florida, 32405
Study site
Pittsburgh, Pennsylvania, 15202
Study site
Searcy, Arkansas
Study site
Shreveport, Louisiana, 71105
Study site
South Jordan, Utah, 84095
Study site
Tampa, Florida, 33603
Study site
Temple, Texas, 76502
Study site
Tifton, Georgia

Other trials in United States

About this study

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

Conditions: Gastroesophageal Reflux Disease, GERD, Heartburn
Being tested: nizatidine (axid), placebo
Keywords: gastroesophageal reflux disease, GERD, heartburn
Medical subject headings: Gastroesophageal Reflux, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nizatidine (axid)Drug
nizatidine (axid)
nizatidine (axid)Drug
nizatidine (axid)
placeboDrug
placebo

Study groups in NCT00373334
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: nizatidine (axid)
2	Experimental	Not described Receives: Drug: nizatidine (axid)
3	Sham comparator	Not described Receives: Drug: placebo

What is being measured

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

Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
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.
Measured: 8 weeks

Secondary outcomes (2)

Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.
Measured: 8 weeks
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.
Measured: 8 weeks

Timeline

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

Aug 2006Feb 2008

First posted8 Sep 2006 (estimated)
Study startAug 2006
Primary completionFeb 2008
Study completionFeb 2008

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 Reflux DiseaseStudies 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: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00373334
Sponsor's protocol ID: BLI-AX-001
Status last verified: Nov 2009
First submitted: 7 Sep 2006
Last updated: 18 Nov 2009
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
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Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00373334
Acronym / sponsor ID: BLI-AX-001
Conditions: Gastroesophageal Reflux Disease, GERD, Heartburn
Keywords: gastroesophageal reflux disease, GERD, heartburn
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 8 Sep 2006 (estimated)
Results: Posted 17 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: nizatidine (axid)
2	Experimental	Drug: nizatidine (axid)
3	Sham comparator	Drug: placebo

Who may qualify

Ages: 30 days to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male or female outpatients age 30 days up to 1 year at Visit 1.
Subjects must have a documented medical diagnosis of gastroesophageal reflux disease (GERD), confirmed by either endoscopy or pH monitoring, or by evaluation of baseline symptoms.
Subjects must be greater than the 3rd percentile of weight and height for their age.
Parents/guardians are competent and willing to provide consent and sign and date the institutional review board (IRB) approved consent form.
Parents/guardians are willing to adhere to study requirements, including applying the conservative GERD management methods.

Key exclusion criteria (15 listed)

Any known esophageal disease or disorder, other than reflux esophagitis.
Any active gastroduodenal ulceration, or clinical or endoscopic evidence of active gastrointestinal bleeding.
Any prior esophageal or gastric surgery.
Concurrent serious systemic disorders, including chronic respiratory disease, chronic neurologic disease, chronic renal disease, chronic liver disease.
Subjects with clinically significant abnormal laboratory findings at screening.

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
nizatidine (axid)nizatidine (axid)	Drug	1
nizatidine (axid)nizatidine (axid)	Drug	2
placeboplacebo	Drug	3

Primary outcome

Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
Time frame: 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.

2 secondary outcomes

Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Time frame: 8 weeks
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Time frame: 8 weeks

Results and safety

Results posted to the registry on 17 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nizatidine 2.5 mg/kg Twice Daily	43	33
Nizatidine 5.0 mg/kg Twice Daily	50	32
Placebo	45	32

Primary outcome: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success

Time frame: 8 weeks. Number. Unit: participants

Measure	Nizatidine 2.5 mg/kg b.i.d. n = 42	Nizatidine 5.0 mg/kg b.i.d. n = 49	Conservative Measures Only n = 42
Value	27	32	31

Nizatidine 5.0 mg/kg b.i.d. vs Conservative Measures Only: p = 0.528, Cochran-Mantel-Haenszel
Nizatidine 2.5 mg/kg b.i.d. vs Conservative Measures Only: p = 0.341, Cochran-Mantel-Haenszel

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nizatidine 2.5 mg/kg b.i.d.	0 of 43 (0%)	27 of 43 (62.8%)	Not reported
Nizatidine 5.0 mg/kg b.i.d.	0 of 50 (0%)	31 of 50 (62%)	Not reported
Conservative Measures Only	1 of 45 (2.2%)	31 of 45 (68.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gastroesophageal Reflux Disease

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.

John McGowan study director

Braintree Laboratories, Inc.

26 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 nizatidine (axid) in people with Gastroesophageal Reflux Disease and GERD, run by Braintree Laboratories at 26 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 8 inclusion and 15 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 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 17 Nov 2009). 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?

Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success (time frame: 8 weeks). 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 NCT00373334.

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 18 Nov 2009.