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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastreoesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of omeprazole suspension

Intervention Type DRUG

omeprazole administered as a multi-unit-pellet system

Intervention Type DRUG

Eligibility Criteria

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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)

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No