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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00426595
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastreoesophageal Reflux Disease	Drug: Administration of omeprazole suspension; Drug: omeprazole administered as a multi-unit-pellet system	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (at the end of the treatment period of 14 days) []

Secondary Outcome Measures

1. Gastric pH (at the end of the treatment period of 14 days) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Myriam Van Winckel, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00426595
• Other Study ID Numbers: 2007/013
• First Posted: Jan 25, 2007
• Last Update Posted: Apr 10, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Cerebral Palsy; Intellectual Disability; Omeprazole

Study Results

No Results Posted as of Apr 10, 2009