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

Gastreoesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426595
• Other study ID #: 2007/013
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2007
• Last updated: April 9, 2009
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2009
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Gastreoesophageal Reflux Disease
• Intellectual Disability

Intervention

Drug:
• Administration of omeprazole suspension

• omeprazole administered as a multi-unit-pellet system

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (at the end of the treatment period of 14 days)
Secondary	Gastric pH (at the end of the treatment period of 14 days)

External Links

•   Website of the University Hospital Ghent