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Study Evaluating Pantoprazole in Children With 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.
 
ClinicalTrials.gov Identifier: NCT00300755
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : May 19, 2010
Last Update Posted : May 19, 2010
Sponsor:
Collaborator:
Nycomed
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: pantoprazole sodium enteric-coated spheroid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
Study Start Date : May 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: 1
Arm 1- Low Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks

Active Comparator: 2
Arm 2- Medium Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks

Active Comparator: 3
Arm 3- High Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks




Primary Outcome Measures :
  1. Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) [ Time Frame: Baseline and 8 weeks ]
    WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.


Secondary Outcome Measures :
  1. Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week [ Time Frame: Baseline and 8 weeks ]
    Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.

  2. Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline [ Time Frame: Baseline and 8 weeks ]
    Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.

  3. Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study [ Time Frame: 8 weeks ]
    Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to undergo endoscopy with required biopsy
  • Ages 1 through 5 years
  • Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

  • History or presence of upper gastrointestinal anatomic or motor disorders
  • Known current or active cow's milk allergy
  • Malignancy
  • Other exclusions apply.

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 ClinicalTrials.gov identifier (NCT number): NCT00300755


Locations
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United States, Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, California
Oakland, California, United States, 94609
Orange, California, United States, 92868
Sacramento, California, United States, 95819
San Diego, California, United States, 92103
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32610
Jacksonville, Florida, United States, 32207
Miami, Florida, United States, 33101
Orlando, Florida, United States, 32806
Pensacola, Florida, United States, 32504
United States, Illinois
Peoria, Illinois, United States, 61603
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
United States, Michigan
Flint, Michigan, United States, 48503
Southfield, Michigan, United States, 48075
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Nebraska
Omaha, Nebraska, United States, 68105
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Egg Harbor Township, New Jersey, United States, 08234
Morristown, New Jersey, United States, 07962
United States, New York
Buffalo, New York, United States, 14222
New York, New York, United States, 10032
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Danville, Pennsylvania, United States, 17822-1320
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, West Virginia
Charleston, West Virginia, United States, 25304
Huntington, West Virginia, United States, 25701-3655
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
London, Ontario, Canada, N6A 4G5
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Montreal, Quebec, Canada, H3H 1P3
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00300755    
Other Study ID Numbers: 3001B3-328
First Posted: March 9, 2006    Key Record Dates
Results First Posted: May 19, 2010
Last Update Posted: May 19, 2010
Last Verified: April 2010
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
GERD
Children
Child
Child, Preschool
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action