Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
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ClinicalTrials.gov Identifier: NCT00426595 |
Recruitment Status :
Completed
First Posted : January 25, 2007
Last Update Posted : April 10, 2009
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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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | April 2007 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | November 2007 |

- Pharmacokinetics (at the end of the treatment period of 14 days)
- Gastric pH (at the end of the treatment period of 14 days)

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426595
Belgium | |
University Hospital Ghent | |
Ghent, Belgium, 9000 |
Principal Investigator: | Myriam Van Winckel, MD, PhD | University Hospital, Ghent |
Additional Information:
Responsible Party: | Myriam Van Winckel, University Hospital Ghent |
ClinicalTrials.gov Identifier: | NCT00426595 History of Changes |
Other Study ID Numbers: |
2007/013 |
First Posted: | January 25, 2007 Key Record Dates |
Last Update Posted: | April 10, 2009 |
Last Verified: | April 2009 |
Cerebral Palsy Intellectual Disability Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
Neurodevelopmental Disorders Mental Disorders Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |