Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00373334 |
Recruitment Status :
Completed
First Posted : September 8, 2006
Results First Posted : November 17, 2009
Last Update Posted : November 18, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease GERD Heartburn | Drug: nizatidine (axid) Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: nizatidine (axid)
nizatidine (axid) |
Experimental: 2 |
Drug: nizatidine (axid)
nizatidine (axid) |
Sham Comparator: 3 |
Drug: placebo
placebo |
- 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.
- Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief [ Time Frame: 8 weeks ]Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.
- Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity [ Time Frame: 8 weeks ]Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.

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Ages Eligible for Study: | up to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373334
United States, Arkansas | |
Hot Springs, Arkansas, United States, 71913 | |
Jonesboro, Arkansas, United States, 72401 | |
Little Rock, Arkansas, United States, 72205 | |
Little Rock, Arkansas, United States, 72211 | |
Searcy, Arkansas, United States | |
United States, California | |
Madiera, California, United States | |
United States, Colorado | |
Centennial, Colorado, United States, 80112 | |
United States, Florida | |
Orlando, Florida, United States | |
Panama City, Florida, United States, 32405 | |
Tampa, Florida, United States, 33603 | |
United States, Georgia | |
Tifton, Georgia, United States | |
United States, Kentucky | |
Owensboro, Kentucky, United States, 42303 | |
United States, Louisiana | |
Shreveport, Louisiana, United States, 71105 | |
United States, Nebraska | |
Lincoln, Nebraska, United States, 68505 | |
United States, North Dakota | |
Bismarck, North Dakota, United States, 58501 | |
Fargo, North Dakota, United States, 58103 | |
United States, Ohio | |
Fairfield, Ohio, United States, 45014 | |
Mason, Ohio, United States, 45040 | |
United States, Pennsylvania | |
Hershey, Pennsylvania, United States | |
Pittsburgh, Pennsylvania, United States, 15202 | |
United States, Tennessee | |
Clarksville, Tennessee, United States, 37043 | |
United States, Texas | |
Houston, Texas, United States, 77004 | |
Missouri City, Texas, United States, 77495 | |
Temple, Texas, United States, 76502 | |
United States, Utah | |
Ogden, Utah, United States, 84405 | |
South Jordan, Utah, United States, 84095 |
Study Director: | John McGowan | Braintree Laboratories, Inc. |
Responsible Party: | John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT00373334 |
Other Study ID Numbers: |
BLI-AX-001 |
First Posted: | September 8, 2006 Key Record Dates |
Results First Posted: | November 17, 2009 |
Last Update Posted: | November 18, 2009 |
Last Verified: | November 2009 |
gastroesophageal reflux disease GERD heartburn |
Gastroesophageal Reflux Esophagitis, Peptic Heartburn Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Esophagitis Gastroenteritis Peptic Ulcer Duodenal Diseases |
Intestinal Diseases Stomach Diseases Signs and Symptoms, Digestive Nizatidine Anti-Ulcer Agents Gastrointestinal Agents Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |