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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00426595
First received: January 23, 2007
Last updated: April 9, 2009
Last verified: April 2009

January 23, 2007
April 9, 2009
April 2007
November 2007   (final data collection date for primary outcome measure)
Pharmacokinetics (at the end of the treatment period of 14 days)
Same as current
Complete list of historical versions of study NCT00426595 on ClinicalTrials.gov Archive Site
Gastric pH (at the end of the treatment period of 14 days)
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastreoesophageal Reflux Disease
  • Drug: Administration of omeprazole suspension
  • Drug: omeprazole administered as a multi-unit-pellet system
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
November 2007
November 2007   (final data collection date for primary outcome measure)

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)
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00426595
2007/013
Not Provided
Myriam Van Winckel, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Myriam Van Winckel, MD, PhD University Hospital, Ghent
University Hospital, Ghent
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP