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NCT00385008 · ClinicalTrials.gov registry record · Phase 3
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00385008: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00385008 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385008, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
Primary Outcome
Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet di
Interventions
- DRUG Combination Product (sumatriptan succinate / naproxen sodium)
- DRUG RELPAX(eletriptan) 40mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-09-13 |
| Est. Completion | 2006-11-24 |
| Phase | Phase 3 |
What the finished NCT00385008 record still lists
NCT00385008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Combination Product (sumatriptan succinate / naproxen sodium) is the first listed.
NCT00385008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00385008 about?
NCT00385008 is a clinical study titled "TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine". An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
What is the current status of trial NCT00385008?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2006-09-13. Estimated completion is 2006-11-24.
What interventions are being tested in trial NCT00385008?
The interventions under investigation include: Combination Product (sumatriptan succinate / naproxen sodium) (DRUG), RELPAX(eletriptan) 40mg Tablet (DRUG).
Who is sponsoring clinical trial NCT00385008?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00385008's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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