NCT00373334CompletedPhase 3
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
Braintree Laboratories0 sites138 target enrollmentStarted: August 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 138
- Primary Endpoint
- Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Days to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female outpatients age 30 days up to 1 year at Visit
- •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
- •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
- •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.
Arms & Interventions
1
Experimental
Intervention: nizatidine (axid) (Drug)
2
Experimental
Intervention: nizatidine (axid) (Drug)
3
Sham Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief(8 weeks)
- Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity(8 weeks)
Investigators
Similar Trials
Completed
Phase 2
A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CChronic Hepatitis CNCT01790100Alios Biopharma Inc.20
Completed
Phase 1
Study of Single and Multiple Doses of ALS-008176 in Healthy VolunteersRespiratory Syncytial Virus InfectionsNCT01906164Alios Biopharma Inc.101
Withdrawn
Phase 2
A Phase 2 Study With CC-220 in Skin SarcoidosisSarcoidosisNCT02192489Celgene
Withdrawn
Phase 1
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicNCT03771885Boehringer Ingelheim
Completed
Phase 2
Talampanel for Amyotrophic Lateral Sclerosis (ALS)ALSNCT00696332Teva Branded Pharmaceutical Products R&D, Inc.559