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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Gastroesophageal Reflux Disease, GERD, Heartburn

Intervention / Treatment
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* Drug: nizatidine (axid)
* Drug: nizatidine (axid)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: nizatidine (axid)<br>* nizatidine (axid)<br>|
| Experimental: 2<br> | Drug: nizatidine (axid)<br>* nizatidine (axid)<br>|
| Sham Comparator: 3<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, gastroesophageal reflux disease, heartburn