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NCT00513760 · ClinicalTrials.gov registry record · NA
Transporter Mediated Uptake of Montelukast
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT00513760 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 27 participants.
The verdict
NCT00513760, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms associated with asthma. Singulair, manufactured by Merck, is a popular LTRA, however its effectiveness varies greatly between individuals. We are interested in understanding why the effectiveness of Singulair varies so greatly. For an oral drug such as Singulair to be effective, the body must efficiently absorb it. We have found that blood levels of Singulair vary greatly between individuals, and we think that this variability is responsible for variability in response. Drug absorption occurs primarily in the intestine. Due to differences in the chemical properties of drugs, some drugs can be absorbed easily while other drugs require help from special proteins produced by the cells that line the intestine. These proteins, or transporters act like turnstiles to allow drugs to move from the intestine to the bloodstream and are known to be inhibited by components of citrus juice. The activity of a transporter can be influenced by individual genetic variability. We think that Singulair requires help from a transport protein to be absorbed and that genetic variability in this transporter leads to variability in the blood level of Singulair. In this proposal we will use citrus juice (grapefruit and orange) to inhibit intestinal membrane transport proteins and show that Singulair requires these transporters to be efficiently absorbed. Eventually, what we learn from this work will allow doctors to quickly test individuals with asthma to determine how well they will absorb Singulair and possibly other LTRAs. Knowing this will allow the doctor to adjust the drug treatment on an individual basis to maximize benefit in the treatment of asthma.
Interventions
- DIETARY_SUPPLEMENT Gatorade
- DIETARY_SUPPLEMENT Grapefruit juice
- DIETARY_SUPPLEMENT Orange Juice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-06 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00513760
The ClinicalTrials.gov registry entry for NCT00513760 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gatorade is the first listed.
NCT00513760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00513760 about?
NCT00513760 is a clinical study titled "Transporter Mediated Uptake of Montelukast". Leukotriene receptor antagonists (LTRAs) are frequently prescribed to reduce the symptoms associated with asthma. Singulair, manufactured by Merck, is a popular LTRA, however its effectiveness varies greatly between individuals. We are interested in understanding why the effectiveness of Singulair v...
What is the current status of trial NCT00513760?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2007-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00513760?
The interventions under investigation include: Gatorade (DIETARY_SUPPLEMENT), Grapefruit juice (DIETARY_SUPPLEMENT), Orange Juice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00513760?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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