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Trial record 1 of 1 for:    NCT00300755
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Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

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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

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 9, 2006
Results First Submitted Date  ICMJE November 30, 2009
Results First Posted Date  ICMJE May 19, 2010
Last Update Posted Date May 19, 2010
Study Start Date  ICMJE May 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
The primary efficacy outcome is the weekly GERD symptom score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
  • Safety and Tolerability
  • individual mean frequency of each GERD symptom
  • individual mean score for respiratory symptoms
  • change in endoscopy results at end of study in patients with a second endoscopy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    Arm 1- Low Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 2
    Arm 2- Medium Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 3
    Arm 3- High Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
Publications * Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2010)
60
Original Enrollment  ICMJE
 (submitted: March 7, 2006)
65
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300755
Other Study ID Numbers  ICMJE 3001B3-328
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Nycomed
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

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