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NCT00382993 · ClinicalTrials.gov registry record · Phase 3

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
169
Enrollment target

NCT00382993 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 169 participants.

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The verdict

NCT00382993, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
169 participants
Enrollment target

Study Summary

This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 2 of 2\]

Interventions

  • DRUG Placebo
  • DRUG Combination Product (sumatriptan succinate/naproxen sodium)

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2006-12
Est. Completion 2007-11
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00382993

The ClinicalTrials.gov registry entry for NCT00382993 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00382993 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00382993 about?

NCT00382993 is a clinical study titled "A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)". This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will trea...

What is the current status of trial NCT00382993?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2006-12. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00382993?

The interventions under investigation include: Placebo (DRUG), Combination Product (sumatriptan succinate/naproxen sodium) (DRUG).

Who is sponsoring clinical trial NCT00382993?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.