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OpenTrials
Completed

NCT Number: NCT00426595

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

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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Key information

Conditions

Gastreoesophageal Reflux Disease

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Administration of omeprazole suspension

Drug

omeprazole administered as a multi-unit-pellet system

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2007
Registry last updated
Apr 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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