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NCT01476124 · ClinicalTrials.gov registry record · Phase 1
Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
A Phase 1 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01476124 is a Phase 1 study that has completed, run by XenoPort. The registered enrollment target is 18 participants.
The verdict
NCT01476124, a Phase 1 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a controlled release formulation of morphine will be given. Blood samples for evaluation of gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect of co-administering both treatments will be assessed using visual analog scales for somnolence/sedation, dizziness and nausea.
Interventions
- DRUG Morphine
- DRUG GEn Placebo
- DRUG morphine Placebo
- DRUG GEn 600 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01476124
The ClinicalTrials.gov registry entry for NCT01476124 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT01476124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01476124 about?
NCT01476124 is a clinical study titled "Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine". This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 m...
What is the current status of trial NCT01476124?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-08. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01476124?
The interventions under investigation include: Morphine (DRUG), GEn Placebo (DRUG), morphine Placebo (DRUG), GEn 600 mg (DRUG).
Who is sponsoring clinical trial NCT01476124?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
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