NCT00426595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

January 23, 2007

Last Update Submit

April 9, 2009

Conditions

Gastreoesophageal Reflux Disease

Outcome Measures

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)

Interventions

Administration of omeprazole suspensionDRUG
omeprazole administered as a multi-unit-pellet systemDRUG

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Myriam Van Winckel, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 10, 2009

Record last verified: 2009-04

Locations

BE(1)