Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Phase 2

Completed

• Conditions: Gastreoesophageal Reflux Disease

• Registration Number: NCT00426595
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Study Start: 2007-04
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Children > 15 kg
• Cerebral palsy and mental retardation with swallowing disorders
• Presence of gastrostomy tube
• GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
• Informed consent

Exclusion Criteria

• Treatment with ciclosporine, tacrolimus, mycofenolate
• Treatment with anticoagulants
• Infection
• Recent start of treatment with known inhibitors of the omeprazole-metabolism
• Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (at the end of the treatment period of 14 days)

Secondary Outcome Measures

Name	Time	Method
Gastric pH (at the end of the treatment period of 14 days)

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium