Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365300
• Other study ID #: 3001B3-329
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2006
• Last updated: April 26, 2010
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Months

Eligibility

Inclusion Criteria:

• term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months

• clinical diagnosis of GERD

• weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

• known history of upper GI anatomic disorders

• history of acute life-threatening medical conditions

• clinically significant medical conditions or laboratory abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• pantoprazole

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Withdrawn From Study Due to Lack of Efficacy.	Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for = 7 continuous days, or severe GERD symptoms based on physician's judgment.	4 weeks double-blind	No