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NCT00989625 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
A Phase 1 study of Migraine Disorders, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT00989625 is a Phase 1 study of Migraine Disorders that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 participants, below the 313-participant average among 21 other Migraine Disorders trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT00989625, a Phase 1 study of Migraine Disorders, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.
Conditions Studied
Interventions
- DRUG This is a pharmacokinetic study (Treximet)
Study Locations (3)
Kansas
- GSK Investigational Site - Wichita
Kentucky
- GSK Investigational Site - Louisville
Tennessee
- GSK Investigational Site - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-11-04 |
| Est. Completion | 2009-09-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00989625
The ClinicalTrials.gov registry entry for NCT00989625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 313-participant average among 21 other Migraine Disorders trials with a reported enrollment target (84% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 1 intervention - of which This is a pharmacokinetic study (Treximet) is the first listed.
NCT00989625 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kansas, Kentucky, Tennessee.
Frequently Asked Questions
What is clinical trial NCT00989625 about?
NCT00989625 is a clinical study titled "A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.". This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent...
What is the current status of trial NCT00989625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2008-11-04. Estimated completion is 2009-09-10.
What conditions does trial NCT00989625 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT00989625?
The interventions under investigation include: This is a pharmacokinetic study (Treximet) (DRUG).
Who is sponsoring clinical trial NCT00989625?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00989625 being conducted?
This trial has 3 study locations across Kansas, Kentucky, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
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-
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-
Responding With Evidence and Access for Childhood Headaches
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-
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-
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
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