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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
GERD
Heartburn
Drug: nizatidine (axid)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 138
Study Start Date: August 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: nizatidine (axid)
nizatidine (axid)
Experimental: 2 Drug: nizatidine (axid)
nizatidine (axid)
Sham Comparator: 3 Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373334

  Show 26 Study Locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00373334     History of Changes
Other Study ID Numbers: BLI-AX-001
Study First Received: September 7, 2006
Results First Received: August 3, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
gastroesophageal reflux disease
GERD
heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Nizatidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014