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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00373334
First received: September 7, 2006
Last updated: November 17, 2009
Last verified: November 2009

September 7, 2006
November 17, 2009
August 2006
February 2008   (final data collection date for primary outcome measure)
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Caregiver completed questionnaire
Complete list of historical versions of study NCT00373334 on ClinicalTrials.gov Archive Site
  • Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Investigator symptom assessment (efficacy)
  • Adverse event reporting (safety)
Not Provided
Not Provided
 
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • GERD
  • Heartburn
  • Drug: nizatidine (axid)
    nizatidine (axid)
  • Drug: placebo
    placebo
  • Experimental: 1
    Intervention: Drug: nizatidine (axid)
  • Experimental: 2
    Intervention: Drug: nizatidine (axid)
  • Sham Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373334
BLI-AX-001
Not Provided
John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
Braintree Laboratories
Not Provided
Study Director: John McGowan Braintree Laboratories, Inc.
Braintree Laboratories
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP