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NCT00006395 · ClinicalTrials.gov registry record · Phase 4
Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers
A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00006395 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 12 participants.
The verdict
NCT00006395, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
St. John's Wort is a popular dietary supplement that many patients-including those with epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve stress. Preliminary research indicates that this supplement can speed the metabolism of the anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take Tegretol to control their seizures may have more frequent seizures if the blood level of the drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken for at least 3 weeks. The present study will examine whether there is a medically important drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day. Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30 days may be eligible for this 25-day study. Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will be drawn the next day during a 12-hour clinic stay at the following intervals: just before the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A catheter will be placed in the vein to prevent the need for multiple needle sticks until after the 10-hour sample. After completing the blood sampling, participants will take 300 mg of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose of Tegretol will be given and the 72-hour blood study will be repeated. This study may provide information important for the care of patients with epilepsy who take both Tegretol and St. John's Wort.
Interventions
- DRUG St. John's Wort
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2000-10 |
| Est. Completion | 2001-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006395
The ClinicalTrials.gov registry entry for NCT00006395 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which St. John's Wort is the first listed.
NCT00006395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006395 about?
NCT00006395 is a clinical study titled "Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers". St. John's Wort is a popular dietary supplement that many patients-including those with epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve stress. Preliminary research indicates that this supplement can speed the metabolism of the anti-seizure drug Tegretol, ...
What is the current status of trial NCT00006395?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2000-10. Estimated completion is 2001-04.
What interventions are being tested in trial NCT00006395?
The interventions under investigation include: St. John's Wort (DRUG).
Who is sponsoring clinical trial NCT00006395?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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