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

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. Identifier: NCT00373334
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : November 17, 2009
Last Update Posted : November 18, 2009
Information provided by:
Braintree Laboratories

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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Nizatidine

Arm Intervention/treatment
Experimental: 1 Drug: nizatidine (axid)
nizatidine (axid)

Experimental: 2 Drug: nizatidine (axid)
nizatidine (axid)

Sham Comparator: 3 Drug: placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00373334

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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
Sponsors and Collaborators
Braintree Laboratories
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Study Director: John McGowan Braintree Laboratories, Inc.
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Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. 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
Keywords provided by Braintree Laboratories:
gastroesophageal reflux disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Signs and Symptoms, Digestive
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs